[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioma":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,154,0,25,[9,60,84,106,128,190,218,257,285,313,332,362,389,408,434,455,477,509,532,567,608,636,666,691,714],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":7},"100618049","phase-2-study-of-silevertinib-with-temozolomide-for-the-treatment-of-newly-diagnosed-gbm-with-unmethylated-mgmt-and-egfrviii-100618049",false,"NCT07326566","Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII","A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII","Key Inclusion Criteria:\n\n* Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT).\n* Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification).\n* For Part 1 (Safety Lead-in) ONLY: EGFR alterations.\n* For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII.\n* For Part 2 (Randomized, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay.\n* No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy.\n* At least 4 weeks since completion of radiation therapy, with a post-radiation MRI showing no progression.\n\nKey Exclusion Criteria:\n\n* Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.\n* Progression of GBM prior to Enrollment, Screening, or Randomization.\n* Biopsy-only\u002Fno resectional surgery.\n* Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy.\n* Intent to use Optune® (TTF).\n* Significant other uncontrolled health conditions or other malignancies.","ALL","18 Years",{"count":20,"type":21},162,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting.\n\nSpecifically, this study is being done to find answers to the following questions:\n\n* How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM?\n* What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)?\n* Can the study drug (silevertinib combined with temozolomide) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?",[27,28,29,30,31,32,33],"Glioblastoma (GBM)","Newly Diagnosed Glioblastoma","GBM","Glioblastoma Multiforme (GBM)","Glioma","Central Nervous System Diseases","Brain Cancer",[35,36,37,38,39,40,41,42,43,44,45,46,47],"EGFR","Glioblastoma","Unmethylated","Unmethylated MGMT promoter","Newly Diagnosed","temozolomide","Temodar","silevertinib","BDTX-1535","EGFR alterations","epidermal growth factor receptor","EGFRvIII","epidermal growth factor receptor (EGFR)","RECRUITING","2026-08-20",{"date":51,"type":52},"2026-08-21","ACTUAL",{"date":54,"type":52},"2026-05-05",{"date":56,"type":21},"2029-03",{"name":58,"class":59},"Black Diamond Therapeutics, Inc.","INDUSTRY",{"id":61,"slug":62,"hasResults":12,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100191818","molecular-testing-for-the-md-anderson-cancer-center-personalized-cancer-therapy-program-100191818","NCT01772771","Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program","Inclusion Criteria:\n\n* Patients must have histologically, radiographic, or cytologically documented cancer, suspected glioma, sarcoma, melanoma or hematologic cancer. Patients with benign tumors may also be consented at the discretion of the attending physician if molecular profiling is felt to have potential clinical implications.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document\n* Patients may be consented without confirming the amount and quality of archival diagnostic or residual tissue available. However, research testing will only be performed on patients who have sufficient archived diagnostic tissue or residual tissue banked in one of the authorized tissue banks at MD Anderson available to proceed with testing. The extent of testing may be modified based on amount of tissue available. If any new tissue acquisition including a biopsy and\u002For surgical resection etc. is being ordered for clinical care or another research study, or an operation is being performed testing can be ordered on that sample\n* Circulating cell-free deoxyribonucleic acid (cfDNA) Cohort: Circulating cell-free DNA next generation sequencing (NGS) testing will be performed with the Clinical Laboratory Improvement Act (CLIA)-certified Guardant360 panel (or equivalent) for select patients. This particular cohort of research collaboration will be supported by Guardant Health, Inc. at no charge to MD Anderson. Patients who are being considered for enrollment into clinical trials in the next 2 lines of therapy may be enrolled. Selected patients may have cfDNA, circulating RNA \u002Fexosome\u002Fcirculating tumor cell testing approaches performed on alternate platforms (eg Foundation ACT)",{"count":67,"type":21},12000,"OBSERVATIONAL","This study performs standardized testing of tumor tissue samples to learn which genes are mutated (have changed) in order to provide personalized cancer therapy options to cancer patients at MD Anderson. This may help doctors use testing information on tumors to identify clinical trials that may be most relevant to patients. Researchers may also use the information learned from this study to develop a database of the different kinds of mutations in cancer-related genes.",[31,71,72,73,74],"Hematopoietic and Lymphoid Cell Neoplasm","Malignant Solid Neoplasm","Melanoma","Sarcoma",{"date":51,"type":52},{"date":77,"type":52},"2012-03-01",{"date":79,"type":21},"2033-03-01",{"name":81,"class":82},"M.D. Anderson Cancer Center","OTHER",1,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":83},"100652912","early-phase-1-multiparametric-metabolic-and-hypoxic-petmri-imaging-substudy-in-gliomas-100652912","NCT07778979","Multiparametric Metabolic and Hypoxic PET\u002FMRI Imaging Substudy in Gliomas","Multiparametric Metabolic and Hypoxic PET\u002FMRI Imaging Substudy for Disease Assessment and Guidance of Catheters in Patients With Recurrent\u002FProgressive Malignant Gliomas Eligible for Catheter-delivered Therapies","Inclusion Criteria:\n\n1. Participants from IRB 300007756\n2. 18 years of age or older at the time of enrollment\n3. Able to undergo PET\u002FMRI without anesthesia or sedation. Minimal sedation with ananxiolytic such as alprazolam used routinely for SOC MRI is allowed.\n4. Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum hCG test within 48 hours prior to the administration of FET or FMISO.\n5. ECOG performance score of 2 or better\n6. Life expectancy greater than 12 weeks.\n\nExclusion Criteria:\n\n1. Any exclusions listed in IRB 300007756\n2. Pregnancy or breast feeding\n3. Inability to complete PET\u002FMRI scans.\n4. Significant renal dysfunction (estimated GFR \\\u003C 30 mL\u002Fmin)\n5. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team\n6. Unable to undergo MRI\n7. Contraindication to gadolinium-based contrast",{"count":92,"type":21},20,[94],"EARLY_PHASE1","This substudy will investigate a new imaging approach using positron emission tomography (PET) and two investigational drugs (\\[18F\\]FET and \\[18F\\]FMISO) to see if the imaging results will help with the placement of catheters for therapy delivery in 20 adult patients with malignant gliomas (MGs) who are participating in the UAB IRB approved main study, A Phase I\u002FII Study of Pembrolizumab and M032 (NSC 733972), a Genetically Engineered HSV-1 Expressing IL-12, in Patients with Recurrent\u002FProgressive and Newly Diagnosed Glioblastoma Multiforme, grade 3 or grade 4 astrocytoma, or Gliosarcoma (IRB 300007756 PI Markert). The PET and MR imaging results will be available to guide catheter placement within IRB 300007756 study-specific guidelines during Neurosurgery.",[31],"NOT_YET_RECRUITING","2026-08-18",{"date":51,"type":52},{"date":101,"type":21},"2026-09",{"date":103,"type":21},"2030-11",{"name":105,"class":82},"University of Alabama at Birmingham",{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":83},"100366130","feasibility-of-intraoperative-microdialysis-during-neurosurgery-for-central-nervous-system-malignancies-100366130","NCT04047264","Feasibility of Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions","Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Diagnosis of the following, based on clinical and radiographic evidence:\n\n  * Any glioma\n  * Metastatic brain tumor of any primary origin\n  * Epileptic focus requiring surgical resection\n* Planned neurosurgical procedure for purposes of biopsy or resection of suspected or previously diagnosed brain tumor (primary or metastatic) or epileptic focus as part of routine clinical care\n* Willing to undergo neurosurgical resection or biopsy at Mayo Clinic \\[Rochester, Minnesota (MN)\\]\n* For patients with gliomas recruited for post-operative microdialysis, willingness to stay in the hospital through post-operative day (POD) 3-5 (timing per physician and patient's shared decision making)\n* Ability to understand and the willingness to sign a written informed consent document\n* Enrollment into the Biobank study (IRB#12-003458)\n\nExclusion Criteria:\n\n* Vulnerable populations: pregnant women, prisoners or the mentally handicapped\n* Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness",{"count":114,"type":21},100,[116],"NA","This clinical trial evaluates the use of microdialysis catheters during surgery to collect biomarkers, and studies the feasibility of intra- and post-operative microdialysis during neurosurgery for central nervous system malignancies. A biomarker is a measurable indicator of the severity or presence of disease state. Information collected in this study may help doctors develop new strategies to better diagnose, monitor, and treat brain tumors.",[31,36,119],"Metastatic Malignant Neoplasm in the Brain","2026-08-14",{"date":98,"type":52},{"date":123,"type":52},"2020-01-01",{"date":125,"type":21},"2027-09-01",{"name":127,"class":82},"Mayo Clinic",{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":136,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":141,"conditions":142,"keywords":162,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100626796","phase-2-determine-trial-treatment-arm-07-dabrafenib-in-combination-with-trametinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-braf-v600-mutation-positive-cancers-100626796","NCT07440290","DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 07 (DABRAFENIB AND TRAMETINIB) OUTLINED BELOW\\* \\*When dabrafenib- and trametinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the dabrafenib- and trametinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring an oncogenic alteration in BRAF V600, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.\n\nB. Patients ≥1 year old and ≥8 kg in body weight.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n• Have a negative serum or urine pregnancy test before enrolment and;\n\n• Agree to use one form of a non-hormonal highly effective contraception method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly; the requirement for non-hormonal method is because dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives), such as: i. intrauterine device (IUD), ii. bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking trial treatment), iii. vasectomised partner, iv. total sexual abstinence. Effective from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nPatients who are breastfeeding must be willing to discontinue breastfeeding from the start of treatment, throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks after the last administration of dabrafenib and 16 weeks after the last administration of trametinib (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (male condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male partners with partners who are women of childbearing potential should also be advised of the benefit for their partner of using a highly effective method of contraception, such as:\n\n  i. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]), ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), iii. IUD, iv. intrauterine hormone-releasing system (IUS), v. bilateral tubal occlusion, vi. total sexual abstinence.\n* Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent drug exposure of the foetus or neonate, even if vasectomised.\n* Male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility\n\nExclusion criteria:\n\nA. Diagnosis of one of the following BRAF V600E mutation-positive cancers:\n\n* Colorectal cancer in adult (≥18 years) patients;\n* Unresectable or metastatic melanoma in adult (≥18 years) patients;\n* Advanced non-small cell lung cancer in adult (≥18 years) patients;\n* Gliomas harbouring a BRAF V600E mutation in paediatric (1 to \\\u003C16 years) or TYA (16 to \\\u003C18 years) patients.\n\nB. Previous treatment with dabrafenib and trametinib in combination (or other BRAF and MEK inhibitors in combination) for the current indication.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for two weeks following their last dose of dabrafenib or 16 weeks following their last dose of trametinib, whichever is later.\n\nD. Known hypersensitivity to dabrafenib or trametinib or any of the excipients. See the current relevant SmPCs (UK) for the full lists.\n\nE. Patients with a history of retinal vein occlusion.\n\nF. Any impairment of gastrointestinal (GI) function of uncontrolled GI disease that may significantly alter the administration or absorption of dabrafenib and\u002For trametinib (e.g. history of diverticulitis, metastases to the GI tract, uncontrolled Crohn's disease, uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome).\n\nG. Clinically significant cardiac or cerebrovascular disease as defined by:\n\n* Unstable angina within three months prior to screening;\n* Myocardial infarction within three months prior to screening;\n* History of documented congestive heart failure (New York Heart Association functional classification III\u002FIV) etc.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months prior to screening.\n\n• Patients with primary central nervous system (CNS) tumours may be considered unless intratumoural bleeding has occurred within two weeks prior to the first dose of dabrafenib and trametinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. Patients who were administered a live, attenuated vaccine within 28 days prior to initiation of treatment, or anticipation of need for such a vaccine during investigational medicinal product (IMP) treatment or within six months after the final dose of dabrafenib and trametinib.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of dabrafenib and trametinib including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided that each of the following conditions are met:\n\n* CD4 count ≥350\u002FµL;\n* Undetectable viral load;\n* Receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* No HIV\u002Facquired immune deficiency syndrome associated opportunistic infection in the last 12 months.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.","1 Year",{"count":138,"type":21},30,[24,140],"PHASE3","This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.\n\nInvestigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,31,158,159,160,161],"Haematological Malignancy","Malignant Neoplasm","Lymphoproliferative Disorders","Neoplasms by Histologic Type","Neoplasms by Site","Gastrointestinal Cancer","Non-Melanoma Skin Cancer (NMSC)","Langerhans Cell Histiocytosis (LCH)","Cancer","Erdheim-Chester Disease","Thyroid Carcinoma, Papillary","Ovarian Neoplasms","Colorectal Neoplasms","Laryngeal Neoplasms","Carcinoma, Non-Small Cell-Lung","Multiple Myeloma","Thyroid Carcinoma, Anaplastic","Solid Tumour","Pancreatic Diseases",[163,164,151,165,166,167,168,169,170,171,147,172,173,174,175,176,177,178,179],"Adult","Antineoplastic Agents","Child","Dabrafenib","Malignancy","Malignant Neoplasms","Molecular Targeted Therapy","Mutation","Neoplasms by Histologic Site","Paediatric","Precision Medicine","Proto-Oncogene Proteins B-raf","Protein Kinase Inhibitors","Rare","Trametinib","Tumour-Agnostic","Young adult","2026-08-13",{"date":182,"type":52},"2026-08-17",{"date":184,"type":52},"2026-04-01",{"date":186,"type":21},"2029-10",{"name":188,"class":82},"Cancer Research UK",27,{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":83},"100542535","phase-1-hypofractionation-trial-of-re-irradiation-in-good-prognosis-recurrent-glioblastoma-100542535","NCT06344130","Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma","A Phase I Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma","* INCLUSION CRITERIA:\n* Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor.\n* Age \\>= 18.\n* KPS \\>= 70%.\n* Previous tumor irradiation to curative-intent doses.\n* Radiation dose constraints must be achievable based on assessment with MRI and treatment planning CT.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>= 1,000\u002FmicroL\n  * Platelets \\>= 100,000\u002FmicroL\n* Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study entry and through 6 months after the last study treatment (restricted period). Individuals who can father children must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last study treatment.\n* The ability of a participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Recent systemic therapy prior to the initiation of the study therapy as follows:\n\n  * Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.\n  * Temozolomide within 2 weeks.\n  * Cytotoxic chemotherapy within 3 weeks.\n  * Any investigational agents within 2 weeks.\n* Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason.\n* Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy.\n* Requiring radiation therapy within 12 months prior to the initiation of study therapy.\n* History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy.\n* Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in individuals of childbearing potential at screening.\n* Participants with known or suspected radiation sensitivity syndromes.\n* Uncontrolled intercurrent illness evaluated by medical history and physical exam that are not stable and would potentially increase the risk to the participant.","120 Years",{"count":199,"type":21},28,[201],"PHASE1","Background:\n\nGlioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.\n\nObjective:\n\nTo find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.\n\nEligibility:\n\nPeople aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.\n\nParticipants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.\n\nParticipants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.\n\nParticipants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.\n\nParticipants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.",[204,31,205],"Astrocytoma","Recurrent Glioblastoma",[207,208,209],"Radiotherapy","Hypofractionation","Re-irradiation",{"date":120,"type":52},{"date":212,"type":52},"2024-10-01",{"date":214,"type":21},"2027-12-31",{"name":216,"class":217},"National Cancer Institute (NCI)","NIH",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":225,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":229,"conditions":230,"keywords":241,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100480603","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799544-as-monotherapy-or-in-combination-in-people-with-advanced-solid-tumors-100480603","NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","16 Years",{"count":227,"type":21},124,[201],"The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[73,31,231,232,168,233,234,235,236,237,238,239,240],"Thyroid Cancer","Non-Small Cell Lung Cancer","Brain Neoplasms","Advanced or Metastatic Solid Tumors","HGG","LGG","Low Grade Glioma","High Grade Glioma","Differentiated Thyroid Cancer","NSCLC (Non-small Cell Lung Cancer)",[242,243,244,245,246,247,248],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600",{"date":120,"type":52},{"date":251,"type":52},"2022-11-30",{"date":253,"type":21},"2029-06-18",{"name":255,"class":59},"Pfizer",83,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":197,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":83},"100528495","plx038-in-primary-central-nervous-system-tumors-containing-myc-or-mycn-amplifications-100528495","NCT06161519","PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications","Phase I\u002FII Trial of PLX038 in Primary Central Nervous System Tumors With and Without MYC or MYCN Amplifications","* INCLUSION CRITERIA:\n* Participants must have documented pathologic diagnosis of confirmed primary central nervous system (CNS) tumor with one of the below diagnoses:\n\n  * Cohort Phase I: Any recurrent or progressive primary CNS tumor, regardless of molecular features.\n  * Cohort Phase IIA: Newly diagnosed MYCN amplified ependymoma after surgery and radiation.\n  * Cohort Phase IIB:\n\n    * Recurrent or progressive MYCN amplified ependymoma, OR\n    * Recurrent or progressive medulloblastoma with MYC or MYCN amplifications\n  * Cohort Phase IIC: Any other recurrent or progressive primary CNS tumor with MYC or MYCN amplifications.\n  * Cohort Phase IID: Any recurrent glioblastoma without MYC or MYCN amplifications.\n\nNOTE 1: Recurrence or progression may involve CNS, extra CNS, or both.\n\nNOTE 2: The presence of MYCN or MYC amplification must be confirmed by documented history. Participants who do not have documented history will be tested by NSR device (via next-generation sequencing panel TruSight(TM) Oncology 500) and the threshold of MYCN or MYC amplification for eligibility purposes is a fold change (FC) of \\>=2.5X (5 copies) with a minimum tumor content of 20%.\n\n* Participants must have archival tumor tissue (either a block or 15 formalin-fixed paraffin-embedded (FFPE) unstained slides) available for NCI LP review of MYC or MYCN amplification status (if necessary) and for correlative studies:\n\n  * Cohorts Phase I, Phase IIB, Phase IIC, and Phase IID: tumor tissue obtained at any point before trial treatment initiation, but preferably from most recent surgical resection before study treatment initiation.\n  * Cohort Phase IIA: tumor tissue obtained at original diagnosis.\n* Participants in Cohort Phase IIA must have completed surgery followed by radiation at least 4 weeks and no more than 10 weeks from the last dose of radiation prior to study treatment initiation.\n* Participants in Cohorts Phase I, Phase IIB, Phase IIC, and Phase IID must have completed prior cytotoxic chemotherapy or radiation at least 4 weeks prior to study treatment initiation (at least 6 weeks if the last regimen included lomustine (CCNU) or carmustine (BCNU); at least 3 weeks if the last regimen included bevacizumab; at least 4 weeks if the last regimen included a checkpoint inhibitor or any other type of immunotherapy or cellular therapy; at least 5 half-lives if the last regimen included any investigational agent(s).\n* Age \\>= 18 years.\n* Karnofsky \\>= 70%. NOTE: Participants with severe paraparesis\u002Fparaplegia who need minimal assistance for self-care due to their motor deficit but are otherwise functionally independent will be eligible.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>=3,000\u002Fmicroliter\n  * absolute neutrophil count \\>1,500\u002Fmicroliter\n  * platelets \\>100,000\u002Fmicroliter\n  * hemoglobin \\>= 9 g\u002F dL (may be transfused within 2 weeks prior to treatment to achieve this level)\n  * total bilirubin within normal institutional limits\n  * aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) \\\u003C2.5 X institutional upper limit of normal (ULN)\n  * creatinine within normal institutional limits OR\n  * estimated glomerular filtrate rate (eGFR) using chronic kidney disease epidemiology collaboration) (CKD-EPI) equation:\\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal\n* Women of child-bearing potential (WOCBP) and those who can father children must agree to use effective contraception (barrier, hormonal contraception, intrauterine device (IUD), surgical sterilization, barrier at the study entry, for the duration of study treatment and up to 6 months (WOCBP) and 3 months (those who can father children) after the last dose of study treatment.\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after the last dose of the study drug.\n* Ability to self-report symptoms and physical function as determined by assessment of the clinical team performed at screening.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions to compounds of similar chemical composition to PLX038.\n* Major surgery within 2 weeks prior to study treatment initiation. NOTE: The surgery is considered major if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges).\n* Participants who require treatment with strong inhibitors or inducers of CYP3A or with UGT1A1 inhibitors during the planned period of investigational treatment with PLX038. Lists including medications and substances known or with the potential to interact with CYP3A or UGT1A1 are provided in https:\u002F\u002Fdrug-interactions.medicine.iu.edu\u002Fmaintable.\n* History of treatment with pegylated topoisomerase inhibitors.\n* Has unresolved or persistent grade 2 or higher GI toxicity from any type of RT at screening\n* Participants with history of homozygous for the UGT1A1\\*28 variant allele with severely reduced UGT1A1 activity.\n* Participants positive for Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), and Hepatitis B virus (HBV).\n* Pregnancy (confirmed with beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening).\n* Participants unable to have MRIs.\n* Prior or concurrent malignancy unless its natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (https:\u002F\u002Fdeainfo.nci.nih.gov\u002Fadvisory\u002Fctac\u002F1117\u002F4-JournalClinicalOncology.pdf, https:\u002F\u002Fctep.cancer.gov\u002FprotocolDevelopment\u002Fdocs\u002FCTEP\\_Broadened\\_Eligibility\\_Criteria\\_Guidance.pdf)\n* Uncontrolled intercurrent illness evaluated by history, weight, and physical exam that would limit compliance with study requirements.",{"count":265,"type":21},146,[201,24],"Background:\n\nAbout 90,000 new cases of brain and spinal cord tumors are diagnosed annually in the United States. Most of these tumors are benign; however, about 30% are malignant, and 35% of people with malignant tumors in the brain and spinal cord will die within 5 years. Many of these people have changes in certain genes (MYC or MYCN) that drive the development of their cancers.\n\nObjective:\n\nTo test a study drug (PLX038) in people with tumors of the brain or spinal cord.\n\nEligibility:\n\nPeople aged 18 years or older with a tumor of the brain or spinal cord. Some participants must also have tumors with changes in the MYC or MYCN genes.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam and blood tests. They will have imaging scans and a test of their heart function. They may need to have a biopsy: A sample of tissue will be removed from their tumor.\n\nPLX038 is given through a tube attached to a needle inserted into a vein in the arm. All participants will receive PLX038 on the first day of each 21-day treatment cycle. They will take a second drug 3 days later to help reduce the risk of infection; for this drug, participants will be shown how to inject themselves under the skin at home.\n\nBlood tests, imaging scans, and other tests will be repeated during study visits. Hair samples will also be collected during these visits. Some participants may have an additional biopsy.\n\nStudy treatment will continue up to 7 months.\n\nFollow-up visits will continue every few months for up to 5 years.",[31,269,270,36],"Medulloblastoma","Ependymoma",[272,273,274,275,276],"Brain Tumors","Recurrent or progressive primary CNS tumors","Patient-Reported Outcomes","Spine Tumors","MYC or MYCN genes","2026-08-11",{"date":279,"type":52},"2026-08-12",{"date":281,"type":52},"2024-01-31",{"date":283,"type":21},"2033-11-14",{"name":216,"class":217},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":312},"100645478","phase-2-safety-and-efficacy-study-of-safusidenib-in-participants-with-idh1-mutant-glioma-who-discontinued-vorasidenib-treatment-due-to-progressive-disease-100645478","NCT07703436","Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease","A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease","Key Inclusion Criteria:\n\n* Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 2021 criteria\n* IDH1 mutation (e.g., R132H\u002FC\u002FG\u002FS\u002FL) based on immunohistochemistry (IHC) (R132H only), PCR, or next generation sequencing (NGS).\n* Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection).\n* Measurable disease per modified RANO 2.0 confirmed by BICR during Screening.\n* Previously treated with vorasidenib and experienced radiographic disease progression during treatment and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. Disease progression must be confirmed by BICR using modified RANO 2.0.\n* Adequate hematologic and organ function\n* Expected survival of ≥12 months\n\nKey Exclusion Criteria:\n\n* Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) and vorasidenib for treatment of glioma.\n* Discontinued vorasidenib for toxicity or any reason other than radiographic disease progression\n* Prior treatment with anti-angiogenic agents such as Avastin (bevacizumab) or investigational agents for glioma.\n* Brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.\n* Significant functional or neurocognitive deficits, including uncontrolled seizures\n* Evidence of leptomeningeal disease.\n* Use of therapeutic doses of steroids for signs\u002Fsymptoms of glioma. Participants taking physiologic doses (defined as equivalent of \\\u003C1.5 mg of dexamethasone equivalent) for medical conditions not related to glioma will be permitted.",{"count":293,"type":21},40,[24],"This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib (confirmed by Blinded Independent Central Review \\[BICR\\] per modified Response Assessment in Neuro-Oncology \\[RANO\\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.",[297,298,31,299,300,301,302,303],"Grade 2 IDH1-mutant Glioma","Grade 3 IDH1-mutant Glioma","IDH1-mutant Glioma","Oligodendroglioma","Oligodendroglioma IDH-1 Mutant and 1\u002Fp19q-codeleted","Astrocytoma IDH Mutant Grade 3","Astrocytoma IDH Mutant Grade 2","2026-08-10",{"date":277,"type":52},{"date":307,"type":21},"2027-03",{"date":309,"type":21},"2032-03",{"name":311,"class":59},"Nuvation Bio Inc.",5,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":331},"100509660","phase-1-a-study-to-test-how-well-different-doses-of-bi-764532-are-tolerated-by-people-with-a-tumour-in-the-brain-that-is-positive-for-dll3-100509660","NCT05916313","A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3","A Phase Ib Open-label, Multi-center, Dose Escalation Trial of BI 764532 Given as Monotherapy Administered by Repeated Intravenous Infusions in Patients With Glioma Expressing DLL3","Inclusion Criteria:\n\n1. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the first informed consent form (ICF1).\n2. Signed and dated written informed consent (ICF1 and ICF2) in accordance with International Council for Harmonisation-Good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.\n3. Patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies.\n4. Availability of archival tumour tissue for Delta-like 3 (DLL3) expression by central assessment.\n5. Tumours must be positive for DLL3 expression by immunohistochemistry (IHC) on archived tumour tissue according to central pathology review.\n6. Documented unequivocal progression after radiotherapy and\u002For chemotherapy with measurable disease by response assessment in neuro-oncology (RANO) criteria.\n7. Karnofsky performance score ≥70. Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Previous treatment in this trial.\n2. Current enrolment in another investigational device or drug trial.\n3. Presence of extracranial metastatic or leptomeningeal disease.\n4. Previous treatment with therapies targeting DLL3.\n5. Prior treatment with bevacizumab or other anti-vascular endothelial growth factor (anti-VEGF) or anti-angiogenic treatment within 6 months prior to first administration of BI 764532.\n6. Recent anti-cancer therapy: treatment with any other anticancer drug within 21 days or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.\n7. Radiotherapy within the 3 months prior to the diagnosis of progression; unless tumour progression is clearly outside the radiation field or tumour progression is unequivocally proven by surgery\u002Fbiopsy.\n\nFurther exclusion criteria apply.",{"count":92,"type":21},[201],"This study (1438-0003) is open to adults with a tumour in the brain that is positive for the tumour marker delta-like 3 (DLL3). This study is in people with advanced cancer for whom previous treatment was not successful.\n\nThe purpose of this study is to find out the highest dose of BI 764532 that people with a brain tumour that is positive for DLL3 can tolerate. BI 764532 is an antibody-like molecule that can attach and link together the cancer cells and T-cells of the immune system (DLL3\u002FCD3 bispecific). This may help the immune system fight cancer.\n\nParticipants get BI 764532 infusions into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is continued. During this time, participants visit the study site at regular intervals. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include staying to monitor participants' safety. Doctors record any unwanted effects and regularly check the general health of the participants.",[31],{"date":277,"type":52},{"date":326,"type":52},"2024-01-30",{"date":328,"type":21},"2027-09-30",{"name":330,"class":59},"Boehringer Ingelheim",12,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":343,"conditions":344,"keywords":348,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":361},"100630364","phase-4-olutasidenib-ddi-study-in-patients-with-idh1-mutation-positive-malignancies-100630364","NCT07486713","Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies","A Multi-Center, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Olutasidenib on the Pharmacokinetics of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates in Patients With IDH1 Mutation-Positive Malignancies Being Treated With Olutasidenib","Inclusion Criteria:\n\n* Adult male or female ≥ 18 years of age at the time of signing the informed consent form\n* Must have an Eastern Cooperative Oncology Group performance status ≤ 2.\n* Must have recovered from the non-hematologic toxic effects of prior treatment to Grade ≤ 1, or baseline value (excluding infertility, alopecia, or Grade 1 neuropathy)\n* Must have a diagnosis of IDH1m+ malignancy to be treated with olutasidenib (e.g. acute myeloid leukemia \\[AML\\], gastrointestinal \\[GI\\] cancers, glioma). Patient should not have received olutasidenib within the 2 weeks prior to the first dose of study drug.\n* Patient must have an adequate organ function, defined by the following:\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≤ 2.5 × upper limit of normal (ULN).\n* Bilirubin ≤ 1.5× ULN (≤ 3 × ULN in patients with Gilbert Syndrome) or ≤ 3 × ULN for patients with AML involvement.\n* Creatinine clearance ≥ 30 mL\u002Fmin using Cockcroft-Gault equation.\n* Female patients who are women of childbearing potential (WOCBP) must have a negative serum (β-hCG) pregnancy test at screening and negative urine test (positive urine tests are to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug. WOCBP are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.\n* WOCBP, must agree to use two methods of birth control (e.g. hormonal and a barrier method such as a condom), or must be considered highly unlikely to conceive during the dosing period and for 3 months after last study treatment.\n* Male patients with female partners of childbearing potential may be enrolled if they both agree to use highly effective methods of contraception during the dosing period and for 3 months after last study treatment.\n* Male patients must refrain from donating sperm during the dosing period and for 3 months after last study treatment.\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breastfeeding.\n* Patients who are active smokers. Those who have ceased smoking \\> 1 month before the Screening Visit will be allowed.\n* Ingestion of alcohol within 72 hours prior to first study drug administration and during the study period.\n* Any patient's who plans to become pregnant or father a child (including ova or sperm donation) while enrolled in this study or within 3 months after last dose of study drug.\n* Known allergy or history of hypersensitivity to study drugs or their excipients.\n* Human immunodeficiency virus (HIV) positivity.\n* Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or by RNA polymerase chain reaction (PCR) at screening.\n* Any patient's with a serious infection requiring intravenous or systemic antibiotics within 7 days prior to initiation of study treatment, or any active infection that, in the opinion of the Investigator, could impact patient's safety (e.g. COVID-19).\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inhibitors within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inducers within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* History of or active, clinically significant, cardiovascular, respiratory, GI, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorder that, in the Investigator's opinion (or following review by the Sponsor), could affect the conduct of the study or the absorption, metabolism or excretion of the study treatment.\n* If less than the minimum time has elapsed from prior anticancer treatment to first dose of study treatment as follows:\n\n  1. Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, or major surgery within 4 weeks prior to the first scheduled study treatment; for longer acting agents such as nitrosourea, mitomycin or antibody therapies, a minimum of 6 weeks.\n  2. Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent).\n* History of prior second malignancy unless disease-free for ≥ 12 months or considered surgically cured. Patients with nonmelanoma skin cancers or with carcinomas in situ at any time following curative intent surgery and low grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to the study, or previously resected are also eligible.\n* Patients with symptomatic central nervous system metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy.\n* Marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\> 480 milliseconds \\[msec\\]) (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 1) using Fridericia's QT correction formula.\n* Patients with New York Heart Association Class III or IV heart failure.",{"count":340,"type":21},16,[342],"PHASE4","A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.",[345,31,346,347],"AML (Acute Myeloid Leukemia)","Cholangiocarcinoma","Solid Tumor Malignancies",[349,350,351,352],"IDH1 Mutation","Hematology and Oncology","Oncology","Drug-Drug Interactions","2026-08-07",{"date":277,"type":52},{"date":356,"type":52},"2026-02-23",{"date":358,"type":21},"2027-06-30",{"name":360,"class":59},"Rigel Pharmaceuticals",2,{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":372,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":386,"locationsCount":4},"100651079","stupp-regimen-with-or-without-lenvatinib-for-newly-diagnosed-glioblastoma-with-mgmt-promoter-methylation-100651079","NCT07754734","STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation","STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation: A Multicenter, Randomized Phase II Clinical Trial","Inclusion Criteria:\n\n* Newly diagnosed GBM confirmed by post-op pathology\u002Fbiopsy, MGMT promoter methylation positive, no prior RT or chemo.\n* Surgery\u002Fbiopsy ≤ 21 days before enrollment.\n* Age 18-75 years any gender.\n* KPS ≥ 70.\n* Organ function (no blood components or growth factors within 14 days):\n\n  1. ANC ≥ 1.5 × 10⁹\u002FL; PLT ≥ 100 × 10⁹\u002FL; Hb ≥ 90 g\u002FL.\n  2. Total bilirubin ≤ 1.5 × ULN.\n  3. ALT, AST ≤ 3 × ULN.\n  4. Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 50 mL\u002Fmin.\n* Life expectancy ≥ 12 weeks.\n* Stable or tapering corticosteroid dose for 14 days.\n* Voluntary participation, signed informed consent, and good compliance.\n\nExclusion Criteria:\n\n* Allergy to Lenvatinib, TMZ, or components.\n* Other malignancies within 5 years or concurrent, or prior anti-tumor therapy.\n* Concurrent participation in another clinical trial (except observational).\n* Comorbidities interfering with treatment:\n\n  1. Grade 4 non-hematological toxicity (except hair loss, nausea, vomiting).\n  2. Conditions interfering with oral drugs (dysphagia, chronic diarrhea, bowel obstruction).\n* Evidence of increased intracranial pressure (midline shift \\> 5 mm, papilledema, vomiting, decreased consciousness).\n* History of drug\u002Falcohol abuse.\n* Pregnancy or lactation.\n* Other conditions judged by the investigator (e.g., unstable heart\u002Fkidney disease, uncontrolled diabetes, mood disorders).","75 Years",{"count":371,"type":21},138,[24],"To compare the efficacy and safety of Lenvatinib combined with the standard Stupp regimen versus the standard Stupp regimen alone in the treatment of newly diagnosed glioblastoma with MGMT promoter methylation positive.",[31,27,375],"MGMT-Methylated Glioblastoma",[377,378,379,380],"Stupp regimen","Lenvatinib","phase II clinical trial","glioblastoma and MGMT promoter methylation","2026-08-06",{"date":304,"type":52},{"date":304,"type":21},{"date":385,"type":21},"2029-07-31",{"name":387,"class":388},"Dongguan People's Hospital","OTHER_GOV",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":361},"100598689","a-digital-treatment-platform-for-the-delivery-of-home-based-sequential-therapy-in-patients-with-glioma-ghost-trial-100598689","NCT07074756","A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma, GHoST Trial","MC240703 Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of glioma and intention to treat with either new or ongoing systemic therapy for at least 6 months.\n\n  * NOTE: Patient may be enrolled following completion of surgery and\u002For radiation therapy for newly diagnosed or recurrent tumor.\n  * NOTE: Any number of prior recurrences is permitted\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 60\n* Expected survival ≥ 6 months in the opinion of treatment team\n* Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations\n* Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only\n\n  * Exception: Not required if patient is already on treatment. May be obtained prior to next treatment as needed per clinical care\n* Provide written informed consent\n* Ability to complete assessments and questionnaires by themselves or with assistance\n* SUBSTUDY 1: Enrolled in GHoST Master Protocol per eligibility criteria of the master study and clinically appropriate to proceed with bevacizumab treatment at the discretion of the treating physician\n* SUBSTUDY 1: Diagnosis of recurrent glioblastoma and intention to treat with bevacizumab\n\n  * NOTE: Any number of prior recurrences is permitted\n  * NOTE: Prior limited use of bevacizumab for radiation necrosis\u002Ftreatment related edema is permitted. Prior use should not exceed four infusions with the last dose administered ≥ 4 weeks prior to enrollment in this substudy\n* SUBSTUDY 1: Willing and able to adhere to the substudy for the duration of the substudy including undergoing treatment, and attending scheduled visits, and examinations\n* SUBSTUDY 1: Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only\n* SUBSTUDY 1: Provide written informed consent\n* SUBSTUDY 1: Ability to complete assessments and questionnaires by themselves or with assistance\n\nExclusion Criteria:\n\n* Pregnant or nursing, imprisoned, or lacking capacity for understanding\n* Uncontrolled and\u002For intercurrent illness or other condition which limits safety of or compliance with study proceedings\n* SUBSTUDY 1: Pregnant or nursing, imprisoned, or lacking capacity for understanding\n* SUBSTUDY 1: Uncontrolled and\u002For intercurrent illness or other condition which limits safety of or compliance with study proceedings",{"count":397,"type":21},202,[116],"This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient. Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease-related disability, or lack of financial resources. The application provides patients continuous access to their care team in the home setting. A digital treatment platform may increase clinical trial participation and accelerate development of novel therapeutics while addressing a great health disparity in patients with glioma.",[31,401,205],"Recurrent Glioma",{"date":304,"type":52},{"date":404,"type":52},"2025-09-12",{"date":406,"type":21},"2028-08-31",{"name":127,"class":82},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":421,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":361},"100650656","proton-vs-photon-radiotherapy-for-patients-with-who-grade-2-3-glioma-100650656","NCT07750457","Proton vs. Photon Radiotherapy for Patients With WHO Grade 2-3 Glioma","Randomized Trial of Radiotherapy With Protons vs. Radiotherapy With Photons for Patients With WHO Grade 2-3 Glioma (GliProPh)","GliProPh","Inclusion Criteria:\n\n* 1\\. Histologically confirmed IDH-mutated WHO Grade 2 or 3 glioma with an indication for radiation therapy as determined by the local tumorboard at the study center\n* 2\\. Tumor classification according to the 2021 WHO Classification, including the presence of the following markers:\n\n  * IDH1\u002F2 mutation\n  * ATRX and\u002For 1p19q codeletion status\n  * CDKN2A\u002FB codeletion status\n* 3\\. A Karnofsky Performance Status of ≥ 70%\n* 4\\. Patients must be ≥ 18 years of age\n* 5\\. Radiation therapy must begin within 7 weeks of surgery in patients with CNS WHO Grade 2 IDH-mutated gliomas. In individual cases, the start may be delayed, but not later than 10 weeks after surgery\n* 6\\. For patients with WHO Grade 2 IDH-mutated CNS gliomas, the following applies:\n\n  * There is an indication for radiation therapy (partial tumor resection, age \\> 40 years, relevant neurological deficit)\n  * Enrollment in the study at the time of tumor progression is possible, even without a time constraint relative to the initial surgery, if the following criteria are met:\n* There was initially no indication for radiation therapy\n* At the time of tumor progression, there is an indication for radiation therapy as determined by the local tumor board\n* At the time of recurrence, no repeat surgery is required to confirm the diagnosis if there is no imaging evidence of malignancy (see exclusion criterion No. 4)\n* Radiation therapy must begin within 7 weeks after the recurrence MRI (or surgery, if a repeat surgery has been performed). In individual cases, treatment may begin later, but no later than 10 weeks after the recurrence MRI\u002Fsurgery\n* 7\\. For patients with WHO Grade 3 IDH-mutated CNS gliomas, radiation therapy must begin within 7 weeks after surgery . In individual cases, treatment may begin later, but no later than 10 weeks after surgery\n* 8\\. At the time of study enrollment, the interval since the last surgery should be ≥ 2 weeks. Patients must have recovered from the effects of the surgery\n* 9\\. The patient must consent and be able to undergo a neurocognitive baseline assessment prior to administration of the first radiation dose\n* 10\\. The patient must provide written informed consent to participate in the study prior to enrollment\n* 11\\. The study participant must be able to understand the purpose and implications of the study and must be willing to follow the clinical study instructions and, as far as can be anticipated, attend all scheduled study visits.\n* 12\\. Women of childbearing potential must have a negative pregnancy test (serum or urine) that is no older than 7 days at the time of the first study intervention.\n* 13\\. Laboratory values not older than 3 weeks prior to study enrollment: Absolute neutrophil count ≥ 1,500\u002Fmm³, Platelet count ≥ 100,000\u002Fmm³, Hemoglobin (Hb) level \\> 10 g\u002FdL, Total bilirubin level ≤ 1.5 times the upper limit of normal, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 3 times the upper limit of normal, Creatinine level ≤ 1.5 times the upper limit of normal\n* Exclusion Criteria Patients who meet any of the following criteria will not be enrolled in the study.\n\nGeneral exclusion criteria:\n\n* 1\\. Concurrent participation in another clinical interventional study or participation in a clinical study that requires administration of an investigational drug within 30 days prior to study enrollment.\n* 2\\. A physical or mental condition of the patient that, in the judgment of the study physician, could endanger the patient, could bias the study results, or could negatively affect the patient's participation in the clinical trial.\n* 3\\. Known or ongoing abuse of drugs, alcohol, or medications.\n\nIndication-specific exclusion criteria:\n\n* 4\\. At the time of tumor recurrence in patients with WHO Grade 2 IDH-mutated CNS gliomas, there is evidence on MRI of malignancy (e.g., marked contrast enhancement indicating Grade 3-4).\n* 5\\. Previous radiation therapy to the head or head and neck region\n* 6\\. Previous chemotherapy due to a CNS neoplasm\n* 7\\. Severe comorbidities that limit compliance with study requirements\n* 8\\. Malignant invasive tumor disease with a tumor-free period of \\\u003C 3 years\n* 9\\. Evidence of leptomeningeal dissemination\n* 10\\. Spinal or infratentorial tumor location\n* 11\\. Patients with a known infection with the human immunodeficiency virus (HIV)\n* 12\\. Patients with a newly diagnosed hepatitis infection or-at the discretion of the responsible study physician-a significant risk of reactivation",{"count":417,"type":21},80,[116],"Patients with grade 2 and 3 gliomas who received photon radiation therapy as part of their standard treatment are at risk of developing cognitive impairments, depending on the tumor's location and the size of the target volume. The extent to which these are caused in individual cases by the brain tissue within the target volume, which is necessarily exposed to a high dose, or whether they can be modified by differences in the exposure of surrounding brain regions exposed to low or moderate doses, is unknown. With the help of proton therapy, the risk of neurocognitive dysfunction could potentially be reduced by decreasing the brain volumes outside the target volume that are exposed to radiation therapy and receive a low dose. Based on current knowledge of relative biological effectiveness, the efficacy of proton therapy on the tumor compared to photon therapy can be considered equivalent with lower levels of uncertainty. In the present study, the impact of photon irradiation versus proton irradiation on neurocognition will now be directly compared. A bicentric, randomized study will investigate whether treating patients with WHO Grade 2 and 3 gliomas with proton radiation results in a different temporal course of neurocognitive function after treatment compared to photon radiation therapy.",[31],[422,423,424,425],"glioma","photon therapy","proton therapy","neurocognitive function","2026-08-04",{"date":381,"type":52},{"date":429,"type":52},"2019-01-15",{"date":431,"type":21},"2033-12-31",{"name":433,"class":82},"University Hospital, Essen",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":369,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":83},"100434954","early-phase-1-study-of-gc101-til-in-brain-glioma-soochow2-100434954","NCT04943913","Study of GC101 TIL in Brain Glioma (Soochow2)","A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Brain Glioma","Inclusion Criteria\n\n1. Age: 18 years to 75 years;\n2. Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized brain glioma;\n3. Expected life-span more than 3 months;\n4. Karnofsky≥60% or ECOG score 0-2;\n5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;\n7. At least 1 evaluable tumor lesion;\n8. Hematology and Chemistry（within 7 days prior to enrollment）:\n\n   * Absolute count of white blood cells≥2.5×10\\^9\u002FL;\n   * Absolute count of neutropils≥1.5×10\\^9\u002FL;\n   * Absolute count of lymphocytes ≥0.7×109\u002FL；\n   * Platelet count≥100×10\\^9；\n   * hemoglobin≥90 g\u002FL;\n   * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin;\n   * Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN);\n   * Totol bilirubin≤1.5×ULN;\n9. No absolute or relative contraindications to operation or biopsy;\n10. Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion；\n11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;\n12. Be able to understand and sign the informed consent document;\n13. Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;\n3. Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.\n4. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;\n5. Severe physical or mental diseases;\n6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);\n7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;\n8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;\n9. Having received immunotherapy and developed irAE level greater than Level 3;\n10. Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);\n11. Females in pregnancy or lactation;\n12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;\n13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",{"count":442,"type":21},50,[94],"This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant glioma . Autologous TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.",[31],"2026-08-03",{"date":448,"type":52},"2026-08-05",{"date":450,"type":52},"2021-05-06",{"date":452,"type":21},"2027-05-31",{"name":454,"class":59},"Shanghai Juncell Therapeutics",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":225,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":293},"100466589","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799933-in-people-with-advanced-solid-tumors-with-braf-alterations-100466589","NCT05355701","A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.","A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS","This study is seeking participants who meet the following key eligibility criteria:\n\nInclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor including primary brain tumor.\n* Qualifying BRAF alteration (V600 or non-V600 Class II\u002FClass III BRAF alteration), in tumor tissue and\u002For blood (ie circulating tumor deoxyribonucleic acid \\[DNA\\], or ctDNA).\n* Disease progressed during\u002Ffollowing last prior treatment and no satisfactory alternative treatment options (Part 1, Part 2 (doublet), and Part 3 (cohorts 2, 3, 6, 7)).\n* Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies\n* Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required, prior MEK inhibitor therapy required, and immune checkpoint inhibitor therapy required.\n* Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required. No prior BRAF inhibitor\u002FEGFR inhibitor allowed. Participants with MSI-H\u002FdMMR mCRC should receive prior immune checkpoint inhibitor therapy.\n* Part 3 (Cohort 5) (BRAF V600E CRC): No more than 2 cycles of prior 5-FU based chemotherapy allowed. No prior BRAF inhibitor\u002FEGFR inhibitors allowed. Participants with MSI-H\u002FdMMR mCRC should receive prior immune checkpoint inhibitor therapy.\n\nExclusion Criteria:\n\n* Brain metastasis larger than 4 cm\n* Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease.\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).",{"count":463,"type":21},267,[201],"The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors.\n\nThis study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called \"BRAF\" and available treatments are no longer effective in controlling their cancer.\n\nAll participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine:\n\n* People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day.\n* People with colorectal cancer may also receive cetuximab or cetuximab and mFOLFOX6 (Chemotherapy regimen). Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV).\n\nParticipants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.",[73,467,231,31,468],"Non-Small-Cell Lung Cancer","Advanced Colorectal Cancer (Part 1)","2026-07-30",{"date":471,"type":52},"2026-07-31",{"date":473,"type":52},"2022-07-05",{"date":475,"type":21},"2029-10-25",{"name":255,"class":59},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":83},"100638426","early-phase-1-feasibility-study-on-the-effect-of-a-methionine-reduced-diet-on-serum-levels-in-pts-w-solid-tumors-100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.",{"count":7,"type":21},[94],"This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[488,489,490,491,492,493,494,495,496,497,73,498,499,500,31],"Adenocarcinoma","Basal Cell Carcinoma","Squamous Cell Carcinoma","Transitional Cell Carcinoma","Ductal Carcinoma","Osteosarcoma","Soft Tissue Sarcoma","Ewing Sarcoma","Rhabdomyosarcoma","Leiomyosarcoma","Germ Cell Tumor","Lymphoma","Endocrine Tumor","2026-07-29",{"date":471,"type":52},{"date":504,"type":52},"2026-05-01",{"date":506,"type":21},"2028-05-01",{"name":508,"class":82},"University of California, Irvine",{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":517,"briefSummary":518,"conditions":519,"keywords":521,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":531},"100628690","phase-1-a-phase-1-safety-and-dose-finding-study-of-glix1-in-adults-with-recurrent-or-progressive-high-grade-glioma-100628690","NCT07464925","A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma","An Open-Label Phase 1 Safety and Dose Finding Study of Orally Administered GLIX1 in Adults With Recurrent or Progressive High-grade Glioma","Main Inclusion Criteria:\n\n* Adult patients aged ≥18 years at the time of informed consent\n* Participants must have histologically confirmed Grade 3 or Grade 4 glioma\n* Recurrent or progressive disease\n* A maximum of two prior treatment lines\n* Interval of at least 3 months since the last day off of radiotherapy, unless tumor progression and index lesion is outside the prior radiation field.\n* Interval since last dose of systemic therapy and Baseline MRI of ≥28 days, except:\n\n  * for nitrosoureas (e.g., lomustine, carmustine, fotemustine): 42 days (6 weeks)\n  * for monoclonal antibodies: 42 days (6 weeks)\n  * for small molecules, 4 weeks or at least 5 half-lives (whatever is longer)\n* Recovered from all toxicities from prior treatments to Grade 1 or less by NCI CTCAE v6.0:\n* Participants receiving corticosteroids must be on a stable or decreasing dose of ≤6 mg daily dexamethasone (or ≤40 mg prednisone) for the 7 days prior to the start of study treatment.\n* Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.\n* Adequate performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1.\n* Ability to swallow tablets or capsules.\n* Adequate hematological, liver and renal function.\n* Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to first dosing. Women must use a highly effective form of contraception (with Pearl Index \\\u003C1%) for the duration of the study and for at least 3 months after the last dose of study medication.\n* Men with partners of childbearing potential must be willing to use condoms in combination with a second effective method of contraception by the partner during the study and for at least 3 months after the last dose of study medication.\n\nMain Exclusion Criteria:\n\n* Known contraindication for gadolinium (Gd) based, contrast-enhanced MRI\n* Prior history of another invasive malignancy unless a complete remission was achieved at least 3 years prior to enrolment AND no additional therapy is required during the study period, except for anti-estrogen or androgen therapy and\u002For bisphosphonates or denosumab.\n* Participants with known active or uncontrolled infection, and\u002For unexplained fever \\>38°C in the 3 days prior to the start of study treatment.\n* Major non-tumor related surgical procedure or significant traumatic injury within 28 days prior to signing of consent.\n* Receiving any investigational products (defined as treatment for which there is currently no regulatory authority-approved indication) within 4 weeks or 5 half-lives (whichever is the longest) prior to Baseline MRI.",{"count":138,"type":21},[201],"This is an open-label, multicenter dose-escalation study to be followed by a dose expansion to define the optimal dose of GLIX1 as monotherapy by reviewing safety and tolerability, disease characteristics and pharmacokinetic profiles and preliminary clinical activity in participants with a high grade diffuse glioma that progressed during or recurred after prior standard of care therapies or investigational therapies as clinically indicated.\n\nPatients will be treated daily with GLIX1 capsules until disease progression or unacceptable safety.",[520,31,36],"Glioblastoma Multiforme of Brain",[522,31,29,36,523],"GLIX1","TET2",{"date":469,"type":52},{"date":526,"type":52},"2026-04-20",{"date":528,"type":21},"2027-12",{"name":530,"class":59},"Tetragon Biosciences Ltd",3,{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":539,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":541,"briefSummary":542,"conditions":543,"keywords":554,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":83},"100624942","phase-1-novel-indenoisoquinolone-cmyctopoisomerase-1-inhibitor-lmp744-in-recurrent-glioblastoma-100624942","NCT07416188","Novel Indenoisoquinolone CMYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","Phase 1\u002FPhase 2 Open Label Trial of a Novel Indenoisoquinolone C-MYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","* INCLUSION CRITERIA:\n\nParticipant must meet all the following inclusion criteria to be deemed eligible for this study:\n\n* Participants \\>= 18 years of age\n* Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist\n* Karnofsky Performance Status (KPS) \\>60\n* Willing to use effective birth control method\n\n  --The effects of LMP744 on developing human fetuses are unknown. Therefore, females of childbearing potential and their male partners must be willing to use an effective method of contraception during the clinical study (hormonal, barrier, surgical, or abstinence) before study enrollment and for 6 months after the last dose of the study drug. If the female becomes pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Agreeable to undergo surgical intervention for brain biopsy and\u002For resection.\n\n  * Initial diagnostic biopsy under 03-N-0164 will be performed to confirm recurrent disease and obtain pre-treatment tissue.\n  * The surgical intervention may include stereotactic\u002Fneedle biopsy, open biopsy, and\u002For resection, as determined by neurosurgical assessment. Only participants for whom gross total resection of tumor is not expected to be achievable will be included in the study.\n* Willing and able to appoint a durable power of attorney\n* Able to provide informed consent or have a legally authorized representative (LAR) to provide consent, if incapacitated.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant and\u002For nursing females\n\n  --As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and\u002For nursing females will be excluded from receiving drug\n* Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and\u002For poorly controlled congestive heart failure)\n* Social situations that would limit compliance with study requirements, such as chronic homelessness\n* Prior chemotherapy or biologic therapy completed within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or a duration of 5 half-lives (whichever is shorter)\n* Additional malignancy diagnosed or requiring active treatment within 1 year of screening\n* Unable to undergo an MRI scan of the brain\n* Active autoimmune disease that requires systemic treatment within 2 years of screening\n* Cardiac disease\n\n  * \\>=2 MIs\n  * \\>=2 coronary revascularization procedures\n  * Cardiac Troponin T or I \\>= 2x the institutional upper limit of normal at screening\n  * Ejection fraction \\\u003C45% on screening echocardiogram\n* Chronic hypokalemia (K\\\u003C2.5 mmol\u002FL)\n* Human Immunodeficiency Virus (HIV)\n\n  * Known history of HIV\n  * Positive HIV 1\u002F2 at screening.\n* Active Hepatitis B or Hepatitis C infection at screening\n* Active infection requiring systemic antibacterial, antiviral or antifungal therapy \\\u003C7 days prior to initiation of study drug\n* Recipient of autologous or allogeneic T cells\n* Solid organ or tissue transplant recipients","99 Years",{"count":293,"type":21},[201,24],"Background:\n\nGlioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells.\n\nObjective:\n\nTo test LMP744 in people with glioblastoma.\n\nEligibility:\n\nPeople aged 18 years or older with glioblastoma that returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function.\n\nParticipants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a \"port\" under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein.\n\nLMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time.\n\nParticipants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery.\n\nParticipants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits.\n\nParticipants will continue to have telehealth visits every 3 months after they stop taking the drug.",[205,544,545,546,547,548,549,31,550,551,29,552,238,553,33],"Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Relapsed Cancer","Recurrent Tumor","Glioblastoma Multiforme","Recurring Glioblastoma","Brain and Central Nervous System Tumors","Glioblastomas","Grade IV Astrocytoma","Recurrent Glioma (Glioblastoma Multiforme)","Glioma, Malignant",[205,31,555,556,557,30,558,559,33],"Neoplasms","Neoplasms, Nerve Tissue","Neoplasms by Histological Type","Phase I","Phase II",{"date":469,"type":52},{"date":562,"type":52},"2026-07-15",{"date":564,"type":21},"2032-12-31",{"name":566,"class":217},"National Institute of Neurological Disorders and Stroke (NINDS)",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":17,"minAge":574,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":22,"phases":576,"briefSummary":577,"conditions":578,"keywords":579,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":83},"100598823","phase-1-engineered-hsv-1-m032-for-the-treatment-of-children-and-adults-with-newly-diagnosed-diffuse-midline-glioma-after-standard-of-care-radiation-100598823","NCT07076498","Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation","Phase 1 Trial of Engineered HSV-1 M032 in Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation","Inclusion Criteria:\n\n* Age ≥ 36 months\n* Newly diagnosed pathologically proven diffuse midline glioma (DMG) (H3 K27M mutant) or radiographic and\u002For pathologically proven pontine DMG (tumors with an epicenter in the pontine and diffuse involvement in at least 50% of the axial diameter of the pons)\n* Patient must have received standard of care radiation ≥ 4 but ≤ 8 weeks prior to study enrollment Note: The eligibility determination, enrollment, pre-surgical planning, and M032 administration must be completed within 8 weeks of radiation therapy completion.\n* The tumor characteristics for enrollment are as follows:\n* The lesion must be ≥ 1.0 cm and ≤ 4.0 cm in diameter and surgically accessible as determined by MRI\n* For patients diagnosed with supratentorial DMG, tumors larger than 4.0 cm may be eligible if they can be surgically debulked to ≤ 4.0 cm\n* Patients must have fully recovered from acute treatment-related toxicities prior to entering this study. The study entry timepoint is defined as the time of consent\n* Previous treatment guidelines (if applicable):\n* Monoclonal antibody (i.e., bevacizumab): patient must have received last dose ≥ 21 days prior\n* Radiation: Patients must have received their last fraction of radiation ≥ 4 weeks and ≤ 8 weeks prior to study entry\n* Temozolomide: Patients must have received their last dose of chemotherapy ≥ 4 weeks prior\n\nNormal hematological, renal, and liver function as defined below:\n\n* Hemoglobin \\> 9g\u002FdL\n* White blood cell ≥ 3,000\u002FμL\n* Absolute neutrophil count ≥ 1000\u002Fmm3\n* Platelets ≥ 100,000\u002Fmm3\n* PT or PTT ≤ 1.3 x control\n* Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m2 (cystatin C preferred) for patients with creatinine levels above institutional normal\n* Total Bilirubin ≤ 1.5 mg\u002Fdl\n* Transaminases \\\u003C 3 times above the upper limits of the institutional norm\n* Patients \\\u003C 16 years, Modified Lansky score ≥ 60; patients ≥ 16 years, Karnofsky score ≥ 60\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of study agent administration.\n* Written informed consent in accordance with institutional and FDA guidelines must be obtained from the patient or legal guardian\n\nExclusion Criteria:\n\n* Patients who previously received other investigational agents\n* Patients with untreated symptomatic hydrocephalus\n* Patients with a radiographic atypical pontine DMG or exophytic glioma, unless biopsy confirmed H3K27M alteration\n* Patients with a primary spinal cord tumor\n* Acute infection, granulocytopenia, or medical condition precluding surgery\n* Pregnant or lactating females: Pregnant women are excluded from this study due to the unknown potential of M032 to cause teratogenic or abortifacient effects. Lactating females are excluded from this study due to the unknown potential risk of adverse effects on both the mother and nursing infants associated with treatment using M032\n* Diagnosis of encephalitis or CNS infection \\\u003C 12 weeks prior\n* Receiving ongoing treatment for encephalitis, CNS infection, or multiple sclerosis\n* Tumor involvement which would require ventricular inoculation or would require access through a ventricle to deliver treatment\n* Patients may not be on immunosuppressive therapy (for at least 1 week), including corticosteroids at the time of enrollment. Physiological replacement of corticosteroids, intermittent use of bronchodilators, or topical steroids will not be excluded from the study.\n* Known HIV seropositivity or known immune deficiency\n* Patient with an active herpes infection with clinical symptomology\n* Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir) or any systemic immunosuppressive drug therapy (except physiological replacement of corticosteroids\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial.\n* Concurrent anticancer or investigational drug\n* Patients with medical contraindications for MRI or MRI contrast agents.\n* Patients who have received a live vaccine within 30 days prior to planned M032 treatment.","36 Months",{"count":92,"type":21},[201],"The goal of this clinical research study is to learn about the safety and effects of M032 given directly into the tumor in children and adults with DMG and who have received standard-of-care radiation therapy.",[31],[580,581,582,583,584,585,586,587,588,589,590,591,592,593,594,595,596,597,598,599,600],"Diffuse Midline Glioma","H3 K27-altered","H3 K27M-mutant","Pediatric Brain Tumor","DMG","Diffuse Intrinsic Pontine Glioma","Supratentorial DMG","DIPG","M032","Oncolytic Herpes Simplex Virus","Oncolytic Virus","oHSV","Immunotherapy","Oncolytic Immunotherapy","Viral Immunotherapy","Intratumoral Therapy","Phase 1 Trial","Pediatric Oncology","Neuro-Oncology","Clinical Trial in Children","Translational Research","2026-07-28",{"date":469,"type":52},{"date":604,"type":52},"2026-04-23",{"date":606,"type":21},"2031-12-31",{"name":81,"class":82},{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":615,"enrollmentInfo":616,"targetDuration":4,"studyType":22,"phases":618,"briefSummary":619,"conditions":620,"keywords":623,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":531},"100648706","feasibility-assessment-of-a-medical-device-for-tumour-cell-retention-and-radiotherapy-sensitization-in-patients-with-suspected-high-grade-glioma-100648706","NCT07725640","Feasibility Assessment of a Medical Device for Tumour Cell Retention and Radiotherapy Sensitization in Patients With Suspected High-grade Glioma","CT-GlioHook","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent prior to the performance of any study-specific procedures.\n2. Age ≥18 and \\\u003C70 years at the time of consent.\n3. Suspected newly diagnosed unifocal high-grade glioma, as suggested by preoperative MRI imaging.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Supratentorial and\u002For lobar tumor mass with a volume of less than 60cm3 as assessed by preoperative MRI.\n6. Patient scheduled to undergo surgical resection of the target brain lesion, with an expected extent of resection (EOR) ≥90% based on preoperative imaging and surgical planning and according to the investigator's criteria. The anticipated EOR should be verified intraoperatively using a validated available method depending on availability at study site, such as 5-aminolevulinic acid (5-ALA) fluorescence guidance, ultrasound, or MRI.\n7. Candidate to receive standard-of-care treatment for newly diagnosed glioblastoma, according to current clinical practice and the investigator's judgment.\n8. Able to undergo contrast-enhanced MRI.\n9. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and study procedures and accessible for follow-up after completion of study treatment.\n10. For women of childbearing potential (WOCBP):\n\n    * Must have a negative serum or urine pregnancy test within 7 days prior to inclusion.\n    * Must not be pregnant or breastfeeding at the time of inclusion.\n    * Must agree to use a highly effective method of contraception during the entire study participation period and for at least 6 months after the last dose of temozolomide.\n11. Male and female patients of reproductive potential must agree to use highly effective contraceptive methods.\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C3 months, as estimated by the investigator.\n2. Surgical resection cannot be assured or is considered not feasible or unsafe based on preoperative assessment.\n3. Tumor located in the posterior fossa or involving critical subcortical structures (e.g., midbrain, brainstem, ventricles, or basal ganglia), where safe surgical resection cannot be achieved.\n4. Presence of multifocal, bilateral, or recurrent tumor, or prior diagnosis of glioblastoma or other intracranial malignancy.\n5. Extent of tumor resection \\\u003C90%. The EOR should be verified intraoperatively using a validated available method depending on availability at study site, such as 5-aminolevulinic acid (5-ALA) fluorescence guidance, ultrasound, or MRI. However, it is up to the neurosurgeon to assess, after reviewing the available data and the resection itself, whether the patient meets the criteria for implantation.\n6. Significant active or uncontrolled concurrent medical conditions, including but not limited to:\n\n   * Active infection requiring systemic therapy,\n   * Symptomatic congestive heart failure,\n   * Unstable angina pectoris,\n   * Clinically significant cardiac arrhythmia,\n   * Uncontrolled hypertension,\n   * Severe pulmonary, hepatic, or renal disease,\n   * Psychiatric or social conditions that, in the opinion of the investigator, would interfere with study compliance or follow-up.\n   * Severe blood clotting disorders\n7. Known hypersensitivity to bovine-derived collagen or other components of the medical device.\n8. Contraindication to contrast-enhanced MRI, including known allergy to gadolinium or presence of non-MRI-compatible implants.\n9. Contraindication to receive radiotherapy or temozolomide, including prior cranial irradiation exceeding safe cumulative dose limits.\n10. Participation in another interventional clinical trial or use of an investigational product within 30 days prior to inclusion, or planned participation during this clinical investigation.\n11. Women who are pregnant or breastfeeding.\n12. Men or women of reproductive potential unwilling to use adequate contraception, as defined in the inclusion criteria.\n13. Inability or unwillingness to comply with clinical investigation procedures, follow-up schedule, or CIP requirements, as judged by the investigator.","70 Years",{"count":617,"type":21},15,[116],"This is a prospective, multicenter, single-arm, pilot clinical investigation, aimed at evaluating the safety and preliminary efficacy of the GlioHook implant in patients with high-grade glioma undergoing surgical resection followed by standard of care (SoC) treatment.\n\nGlioHook is a sterile medical device designed to be implanted after tumour resection surgery in suspected high grade glioma patients, covering the entire surface of the tumour resection margins, decreasing infiltration and focalizing the disease, while improving the effects of radiotherapy. Once implanted, GlioHook exerts a dual mechanism that combines tumour cell focalization and radiosensitization.",[31,621,622],"High-Grade Glioma (HGG)","Surgical Resection",[624,625,207,626],"Implant","High-Grade Glioma","Temozolomide","2026-07-24",{"date":629,"type":52},"2026-07-27",{"date":631,"type":21},"2026-10-30",{"date":633,"type":21},"2028-10-30",{"name":635,"class":59},"Batea Oncology",{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":641,"acronym":4,"eligibilityCriteria":642,"healthyVolunteers":12,"sex":17,"minAge":643,"maxAge":644,"enrollmentInfo":645,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":647,"conditions":648,"keywords":652,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":662,"leadSponsor":664,"locationsCount":4},"100645498","ai-assisted-mri-molecular-subtyping-in-pediatric-brain-tumors-100645498","NCT07703605","AI-Assisted MRI Molecular Subtyping in Pediatric Brain Tumors","AI-Assisted Presurgical MRI Molecular Subtyping for Pediatric Brain Tumors: A Single-Center Ambispective Clinical Cohort Study","Inclusion Criteria:\n\n* Age younger than 18 years at the time of index surgery.\n* Evaluated at a participating study center and scheduled for first surgical treatment of a suspected target pediatric brain tumor.\n* Preoperative brain MRI available before surgery, including at minimum T1-weighted, contrast-enhanced T1-weighted, T2-weighted, and FLAIR sequences in DICOM format; MRI preferably performed within 7 days before surgery and before biopsy or tumor-directed therapy.\n* Postoperative histopathology confirming one of the following target tumor categories: glioma, medulloblastoma, ependymoma, atypical teratoid\u002Frhabdoid tumor, intracranial germ cell tumors, craniopharyngioma, or choroid plexus tumors.\n* For the prospective cohort, written informed consent provided by a parent or legal guardian, with child assent obtained when appropriate according to age, understanding, and local ethics requirements.\n\nExclusion Criteria:\n\n* Postoperative pathology confirming a non-target tumor type.\n* Recurrent tumor, repeat surgery, or prior tumor-directed surgery before the index surgery.\n* Preoperative MRI of inadequate quality for analysis, including severe motion artifact, severe susceptibility\u002Fmetal artifact, or incomplete field of view.\n* Prior biopsy, radiotherapy, chemotherapy, or other tumor-directed treatment before the index preoperative MRI that is judged to substantially affect imaging interpretation.\n* Concurrent malignant disease other than the target brain tumor.\n* Inability to comply with follow-up requirements in the prospective cohort, in the investigator's judgment, because of severe comorbidity or other practical limitations.","0 Years","17 Years",{"count":646,"type":21},1400,"This multicenter observational cohort study aims to develop and validate an artificial intelligence (AI)-assisted diagnostic system for preoperative molecular subtyping of pediatric brain tumors using routine magnetic resonance imaging (MRI). The study will include seven major pediatric brain tumor categories: glioma, medulloblastoma, ependymoma, atypical teratoid\u002Frhabdoid tumor (AT\u002FRT), intracranial germ cell tumors, craniopharyngioma, and choroid plexus tumors.\n\nThe study includes a retrospective cohort for model development and internal\u002Fexternal validation, and a prospective cohort for further validation. Retrospective data will be collected from pediatric patients who underwent first surgical treatment between January 1, 2020 and December 31, 2025. Prospective enrollment will begin on July 15, 2026, with an anticipated sample size of 150 participants. The AI system will analyze preoperative MRI sequences, including T1-weighted, contrast-enhanced T1-weighted, T2-weighted, and FLAIR images, to predict key molecular markers and integrated diagnostic categories. The primary objective is to evaluate the diagnostic performance of the AI system for prespecified molecular prediction tasks using postoperative histopathology and molecular testing as the reference standard. Secondary objectives include assessing agreement with integrated diagnosis, comparing performance against blinded radiologists, and exploring prognostic associations of AI-predicted subgroups.",[649,31,269,270,650,651],"Pediatric Brain Tumors","Craniopharyngioma","Choroid Plexus Tumors",[653,654,655,656,657],"Artificial Intelligence","Molecular Subtyping","Diagnostic Performance","Deep Learning","Pediatric Neuro-Oncology","2026-07-21",{"date":660,"type":52},"2026-07-23",{"date":562,"type":21},{"date":663,"type":21},"2029-12-30",{"name":665,"class":82},"Huashan Hospital",{"id":667,"slug":668,"hasResults":12,"nctId":669,"briefTitle":670,"officialTitle":671,"acronym":4,"eligibilityCriteria":672,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":673,"targetDuration":4,"studyType":22,"phases":675,"briefSummary":676,"conditions":677,"keywords":678,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":690},"100453743","phase-2-pembrolizumab-olaparib-and-temozolomide-for-people-with-glioma-100453743","NCT05188508","Pembrolizumab, Olaparib, and Temozolomide for People With Glioma","A Phase II Study of Pembrolizumab, Olaparib, and Temozolomide in Patients With Glioma","Inclusion Criteria:\n\nSafety Lead-In and Cohort A specific inclusion:\n\n1. Histologically confirmed grade II or III IDH-mutated glioma (absence of known CDKN2A\u002FB deletion) that has recurred after first line therapy (consisting of at least maximum feasible surgical resection). There is no limit on the number of prior therapies or types of therapies patients can have received.\n2. Measurable disease by RANO criteria\n3. Stable dose of corticosteroids for ≥ 4 weeks prior to baseline MRI. Steroid dose not to exceed 2mg\u002Fday dexamethasone (or equivalent).\n\nCohort B specific inclusion:\n\n1. Histologically confirmed IDH-wildtype glioma that has recurred following therapy (consisting of at least maximum feasible surgical resection and radiation therapy).\n2. Standard of care next generation sequencing via a CLIA certified platform must be available or planned and at a minimum include IDH status.\n3. Patient with known or suspected deleterious mutations in at least 1 of the specified 15 genes involved in homologous recombination repair (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L)\n4. Measurable disease by RANO criteria\n5. Stable dose of corticosteroids for ≥ 4 weeks prior to baseline MRI. Steroid dose not to exceed 2mg\u002Fday dexamethasone (or equivalent).\n\nAll Cohorts:\n\n1. Patients or their Legally Authorized Representative (LAR) must provide written informed consent prior to any screening procedures\n2. Age 18 or older\n3. ECOG 0 or 1 (KPS ≥ 70) (A lower KPS may be acceptable with prior approval from PI)\n4. Willing and able to comply with scheduled visits, treatment plan, and laboratory tests\n5. Patient must be able to swallow and retain oral medication\n6. Patient must have adequate organ function as defined in the following table. Stable dose of corticosteroids for ≥ 5 days prior to baseline MRI.\n7. Before starting study treatment, patients must have recovered to grade 1 from prior therapy (except for residual alopecia or grade 2 peripheral neuropathy).\n8. At least 5 half-lives must have elapsed since any prior signaling pathway modulators (e.g., EGFR, FGFR, or other tyrosine kinase inhibitors), at least 3 weeks must have elapsed since temozolomide, 4 weeks must have elapsed since carboplatin or cisplatin, and at least 6 weeks must have elapsed from nitrosoureas (e.g., BCNU, CCNU). At least 5 half-lives much have elapsed since prior IDH-inhibitor use. In general, at least 4 weeks must have elapsed from any other anticancer drug therapy (e.g. bevacizumab).\n9. Patients must be able to undergo contrast-enhanced MRI scans.\n10. Patients must have shown unequivocal evidence for tumor progression by MRI in comparison to a prior scan\n11. At least 12 weeks elapsed since prior radiotherapy\n12. Life expectancy greater than 12 weeks\n13. A woman of childbearing potential (WOCBP) must not have a positive urine pregnancy test within 72 hours prior to allocation.Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 12 months after the last dose of the study therapy.\n14. Male participants must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days following the last dose of study treatment and refrain from donation sperm during this period.\n15. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    i. Not a WOCBP or ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period for at least 120 days after the last dose of study treatment. Note: Cases of pregnancy that occur during maternal exposures to treatment should be reported. If a patient is determined to be pregnant following treatment initiation, treatment must be discontinued immediately.\n16. Women must agree not to breast feed while on therapy and for at least 120 days following the last dose of study drug.\n\n    * Hematological Absolute neutrophil count (ANC) ≥1500\u002FμL Platelets ≥100 000\u002FμL Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL\n    * Renal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\\u003C1.5 × institutional ULN\n    * Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)\n    * Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nExclusion Criteria:\n\n1. No limit on number of prior therapies\n2. Evidence of significant intracranial hemorrhage\n3. No other investigational or standard anti-tumor therapy allowed\n4. Patients must not have a known history of allergic reaction attributed to study drugs or compounds of similar chemical or biologic composition unless allergic reaction was managed by pre-medication.\n5. Patients must not have a serious pre-existing medical condition or uncontrolled intercurrent illness that would preclude participation in this study (for example, uncontrolled ventricular arrhythmia, interstitial lung disease, severe dyspnea at rest of requiring oxygen therapy, history of major surgical resection involving the stomach or bowel, or pre-existing Crohn's disease or ulcerative colitis or other autoimmune disease,) or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n6. Patients must not have a diagnosis of immunodeficiency or be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n7. Patients must not have an active systemic fungal and\u002For known viral infection (for example human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies).\n8. Patients must not have a history of active tuberculosis.\n9. Patients must not have an active infection requiring systemic therapy\n10. Patients must not have known history of, or any evidence of active, non-infectious pneumonitis\n11. Concomitant use of known strong CYP3A inhibitors (itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir)\n12. Concomitant use of known strong CYP3A inducers (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St. John's Wort)\n13. A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to allocation.\n14. Patients must not have other active concurrent malignancy. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n15. Patients must not have active autoimmune disease that required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.\n16. Patients must not have received a live vaccine within 30 days of planned start of study (Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccine and are not allowed)\n17. Concurrent treatment on another clinical trial. Supportive care trials or nontherapeutic trials (i.e. quality of life) are allowed.",{"count":674,"type":21},57,[24],"This study will test the safety and effectiveness of a combination of pembrolizumab, olaparib, and temozolomide to see how well these drugs work when given together in people with a glioma that either did not respond to previous treatment or came back after treatment.",[31],[679,680,626,681],"Pembrolizumab","Olaparib","20-091",{"date":683,"type":52},"2026-07-22",{"date":685,"type":52},"2022-01-14",{"date":687,"type":21},"2027-01",{"name":689,"class":82},"Memorial Sloan Kettering Cancer Center",10,{"id":692,"slug":693,"hasResults":12,"nctId":694,"briefTitle":695,"officialTitle":696,"acronym":4,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":698,"targetDuration":4,"studyType":22,"phases":700,"briefSummary":701,"conditions":702,"keywords":704,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":706,"lastUpdatePostDateStruct":707,"startDateStruct":708,"completionDateStruct":710,"leadSponsor":712,"locationsCount":83},"100630523","language-network-prehab-via-fmri-neurofeedback-100630523","NCT07488780","Language Network Prehab Via fMRI Neurofeedback","fMRI Neurofeedback for Prehabilitation of the Language Network in Patients Undergoing Radical Glioma Surgery","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Diagnosis of WHO grade II-III glioma involving eloquent language cortex\n* Scheduled for surgical resection\n* MRI-compatible\n* Ability to perform the simple language tasks required for fMRI and neurofeedback\n* Residence within 2 hours of Yale MRRC and ability and willingness to make multiple visits for study participation\n\nExclusion Criteria:\n\n* Severe baseline aphasia precluding task performance\n* Contraindications to MRI\n* Significant cognitive\u002Fpsychiatric comorbidity limiting compliance\n* Concurrent enrollment in other interventional trials\n* Claustrophobia of a degree that they cannot comfortably be scanned\n* Inability or unwillingness to understand or follow the instructions\n* Pregnancy or possible pregnancy",{"count":699,"type":21},4,[116],"This is an interventional neuroimaging study that will examine whether fMRI neurofeedback can shift language network activity away from regions affected by glioma prior to surgery.",[31,703],"Glioma Surgery",[705],"fMRI","2026-07-17",{"date":658,"type":52},{"date":709,"type":21},"2026-08",{"date":711,"type":21},"2026-12",{"name":713,"class":82},"Yale University",{"id":715,"slug":716,"hasResults":12,"nctId":717,"briefTitle":718,"officialTitle":719,"acronym":720,"eligibilityCriteria":721,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":722,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":724,"conditions":725,"keywords":729,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":742,"lastUpdatePostDateStruct":743,"startDateStruct":744,"completionDateStruct":746,"leadSponsor":747,"locationsCount":83},"100648036","connectome-guided-onco-functional-resection-with-tractography-extended-neuronavigation-in-brain-tumor-surgery-100648036","NCT07717827","Connectome-guided Onco-functional Resection With Tractography-Extended Neuronavigation in Brain Tumor Surgery","Connectome-guided Onco-functional Resection With Tractography-Extended Neuronavigation in Brain Tumor Surgery Involving Eloquent Regions: a Prospective Single-centre Cohort Study Integrating Advanced Diffusion MRI Into Clinical Neuronavigation for Gliomas and Metastases","CORTEx","Inclusion Criteria:\n\n* Indication for supratentorial brain tumor surgery (glioma or metastasis)\n* Lesion located within or adjacent to eloquent cortical or subcortical regions (motor, language, visual, or higher-order associative networks, as defined by clinical and neuroimaging criteria)\n* Availability of standardized preoperative and early postoperative brain MRI (including high-direction diffusion tensor imaging, ≥64 directions)\n* Consistent postoperative clinical follow-up planned at the treating centre\n* Provision of informed consent for use of anonymized clinical and imaging data\n\nExclusion Criteria:\n\n* Inability to undergo pre- or postoperative MRI\n* Significant comorbidities precluding surgery\n* Incomplete imaging or clinical data\n* Purely infratentorial lesions or non-tumoral pathologies",{"count":723,"type":21},400,"Brain tumor surgery in so-called \"eloquent\" brain areas aims to remove as much tumor as possible while preserving neurological functions. Standard surgical planning typically focuses on discrete, anatomically defined cortical regions. However, modern neuroscience demonstrates that most brain functions arise from distributed networks of interconnected areas rather than isolated spots - a concept that standard navigation tools do not fully capture.\n\nThe CORTEX study evaluates a surgical workflow - termed \"connectome-guided network-based navigation\" - in which advanced diffusion MRI processing is used to reconstruct patient-specific maps of white matter pathways and large-scale brain networks. These maps are imported into a clinical neuronavigation system to guide preoperative planning and intraoperative decision-making for patients with gliomas or brain metastases in eloquent regions.\n\nThe primary aims are to determine how often network-based information leads to meaningful changes in surgical strategy compared with conventional anatomy-based planning, and to assess early neurological outcomes. Secondary objectives include characterizing the extent of tumor removal, the proximity of the resection to critical white matter tracts, and the feasibility of implementing this pipeline in a high-volume clinical setting.",[726,31,727,728],"Brain (Nervous System) Cancers","Brain Metastasases","Brain Connectivity",[730,731,732,733,734,735,736,422,737,738,739,740,741,720],"diffusion MRI","tractography","neuronavigation","connectome","eloquent cortex","brain tumor surgery","white matter","brain metastasis","extent of resection","onco-functional balance","network neuroscience","neural networks","2026-07-16",{"date":658,"type":52},{"date":745,"type":52},"2022-01-01",{"date":528,"type":21},{"name":748,"class":82},"ARNAS Civico Di Cristina Benfratelli Hospital"]