[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-metastases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-metastases":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,86,0,25,[9,43,72,94,119,141,168,193,215,235,263,283,304,334,406,437,470,492,515,535,559,582,608,634,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100579303","phase-2-a-single-arm-phase-2-study-of-datopotamab-deruxtecan-carboplatin-and-pembrolizumab-for-treatment-naive-brain-metastases-from-nsclc-non-small-cell-lung-cancer-100579303",false,"NCT06822543","A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)","TROPICAL-1","Inclusion Criteria:\n\n\\- Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with a histologically confirmed diagnosis of NSCLC will be enrolled in this study.\n\nHistologically confirmed metastatic non-squamous NSCLC with PD-L1 tumor proportion score \\\u003C50% determined by local or central laboratory using antibodies 22C3'\n\n* Documented negative test results for EGFR and ALK actionable genomic alterations by local test;\n* No known actionable genomic alterations in ROS1, NTRK, RET, HER2, or MET.\n* No prior systemic therapy for advanced or metastatic NSCLC. Patients who received chemotherapy or immunotherapy for localized or locally advanced NSCLC are eligible if progression occurred at least 6 months after the last dose of systemic treatment.\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have measurable disease based on RECIST 1.1, including the following:\n\nPresence of 1 or more measurable central nervous system (CNS) metastases that have not received prior radiation therapy, or presence of 1 or more measurable central nervous system (CNS) metastases that has received prior radiation therapy but has unequivocally progressed within the radiation therapy field; Measurable brain metastasis is defined as any lesion that can be accurately measured in at least one dimension as ≥ 10mm. Patients with brain metastases lesions ≥ 5 mm and \\\u003C 10 mm are considered to have measurable disease and are allowed to be enrolled if MRI slice thickness is 1.5 mm or less.\n\nPresence of 1 or more measurable extracranial lesion; Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\n\\- No neurological symptoms that require immediate and significant intervention, in the opinion of the treating physician. Patients with neurologic symptoms that do not require significant medical intervention are allowed. Patients may also be enrolled after control of neurological symptoms that require immediate and significant intervention.\n\nPatients with neurologic symptoms that are controlled with anticonvulsants are allowed.\n\nPatients with neurologic symptoms that are controlled with stable (for at least 1 week), low dose dexamethasone (≤4 mg daily) are allowed.\n\n* No leptomeningeal carcinomatosis.\n* Archival tumor tissue sample or newly obtained \\[core, incisional or excisional\\] biopsy of a tumor lesion has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slide (preferably a minimum of 20 slides).\n\nHave an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n\nLife expectancy of \\> 12 weeks.\n\nHas had an adequate treatment washout period before Cycle 1 Day 1, defined as:\n\nMajor surgery: ≥ 3 weeks. Chloroquine\u002Fhydroxychloroquine: \\> 14 days.\n\n\\- Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to inclusion.\n\nNote: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n\n\\- Hepatitis B screening tests are not required unless: Known history of HBV infection. As mandated by local health authority. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\n\\- Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to inclusion.\n\nHepatitis C screening tests are not required unless:\n\nKnown history of HCV infection As mandated by local health authority\n\n\\- HIV-infected participants must have well-controlled HIV on ART, defined as: Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n\n\\- It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n\nParticipants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors\u002Finducers\u002Fsubstrates (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers)\n\n* Negative pregnancy test (serum) for women of childbearing potential.\n* Have adequate organ function. Specimens must be collected within 10 days prior to the start of study intervention.\n* Hematological: Absolute neutrophil count (ANC) ≥1500\u002FµL; Platelets ≥100 000\u002FµL; Hemoglobin\n\n  ≥9.0 g\u002FdL or ≥5.6 mmol\u002FLa;\n* Renal: Creatinine OR Measured or calculatedb 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 \\>1.5 × 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* ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\n  1. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within the last 2 weeks.\n  2. Creatinine clearance (CrCl) should be calculated per institutional standard.\n\nExclusion Criteria:\n\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to inclusion.\n* Has received prior radiotherapy to the brain within 2 weeks of the start of therapy, or received radiotherapy to the chest within 4 weeks of start of therapy, or that have ongoing radiation-related toxicities requiring corticosteroid.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Has a diagnosis of immunodeficiency or is 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. Use of dexamethasone ≤ 4 mg\u002Fday (or another steroid at equivalent doses) is allowed for treatment of neurological symptoms.\n* Has spinal cord compression.\n* Uncontrolled or significant cardiovascular disease, including: Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval \\>470 msec regardless of sex; Myocardial infarction within 6 months prior to inclusion; Uncontrolled angina pectoris within 6 months prior to inclusion; Known LVEF \\\u003C50% by ECHO or MUGA scan within 28 days before inclusion; New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening; Uncontrolled hypertension within 7 days before inclusion.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, which have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n* Has severe hypersensitivity (≥Grade 3) to either pembrolizumab and\u002For any of its excipients and\u002For Dato-DXd including its excipients (e.g. polysorbate 80).\n* Has a history of non-infectious ILD\u002Fpneumonitis including radiation pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses (including pulmonary embolism within 3 months of enrollment, severe asthma, severe oxygen-dependent chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion) or autoimmune disease with lung involvement (i.e. rheumatoid arthritis, Sjogren disease, sarcoidosis, etc) with pulmonary involvement documented or suspected at screening.\n* Clinically significant known corneal disease.\n* Known active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n* Severe infection within 4 weeks prior to the first dose of study treatment (Cycle 1, Day 1), including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.\n* Treatment with oral or IV antibiotics within 2 weeks prior to initiation of study treatment (Cycle 1, Day 1).\n* Has not adequately recovered from major surgery or has ongoing surgical complications.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting 3 months before Cycle 1 Day 1 and continuing for at least 6 months for male subjects and 7 months for female subjects after the last dose.\n* Female participants must be at least 1 year post-menopausal, surgically sterile, or using at least 1 highly effective form of birth control (a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.) Women of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of birth control. They should have been stable on their chosen method of birth control for a minimum of 3 months before Cycle 1 Day 1 and continue for at least 7 months after the last dose. Female participants must refrain from egg cell donation or retrieval for their own use, and breastfeeding from first dose throughout the study and for at least 7 months after the last dose of study drug. Any non-sterilized male partner of a woman of childbearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) throughout this period.\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or use an acceptable method of contraception from the time of screening throughout the total duration of the study and the drug washout period (at least 6 months after the last dose of study intervention), in addition to the female partner using a highly effective contraceptive method, to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period. Preservation of sperm should be considered prior to inclusion. Not engaging in heterosexual activity (sexual abstinence) for the duration of the study and drug washout period is an acceptable practice, if this is the preferred usual lifestyle of the participant. Periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n* Has had an allogenic tissue\u002Fsolid organ transplant.","ALL","18 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase II, single-arm, multicenter trial for patients with metastatic non-small cell lung cancer who have brain metastases and no known actionable mutations. Eligible patients will receive a combination of Datopotamab-deruxtecan, Carboplatin, and Pembrolizumab every three weeks for four cycles, followed by maintenance therapy with Datopotamab-deruxtecan and Pembrolizumab until disease progression or intolerable toxicity. Patients with intracranial progression but no systemic progression may receive stereotactic radiosurgery and continue treatment based on the investigator's decision.",[27,28,29],"Lung Cancer","Non Small Cell Lung Cancer","Brain Metastases","RECRUITING","2026-08-14",{"date":33,"type":34},"2026-08-18","ACTUAL",{"date":36,"type":34},"2025-09-12",{"date":38,"type":21},"2028-11-01",{"name":40,"class":41},"Latin American Cooperative Oncology Group","OTHER",13,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100603705","phase-1-personalized-radiotherapy-for-individualized-treatment-strategies-and-monitoring-prism-100603705","NCT07139990","Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)","Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types","PRISM","Inclusion Criteria:\n\nCohort A:\n\n* \\>=18 years old\n* Performance status ECOG 0-2\n* Extensive stage small cell lung cancer diagnosed by tissue biopsy within 180 days of registration.\n* Patient must be planned for or receiving standard of care chemoimmunotherapy.\n* Patient must have received no more than 3 cycles by time of study enrollment.\n* Able and indicated according to investigator to receive thoracic radiotherapy\n\nCohort B:\n\n* 18 years old\n* Diagnosis of solid tumor malignancy with MRI-defined brain metastasis lesions within 60 days of registration\n* Each brain metastasis lesion enrolled must be 2 - 5 cm, except brainstem lesions which may be 1.5 - 5cm in size.\n\nCohort C:\n\n* \\>=18 years old\n* Performance status ECOG 0-2\n* Histologically confirmed surgically resectable, high grade (FNCLCC grade 2 or 3), localized soft tissue sarcoma of the trunk or extremities that measures \\>5 cm in any direction as assessed by imaging\n* Eligible to receive immunotherapy\n\nCohort D:\n\n* \\>=18 years old\n* Performance status ECOG 0-2\n* Pathologically proven diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx\n* Clinical stage III\u002FIVA (AJCC 8th edition)\n* Disease must be deemed resectable by head and neck surgeon\n* Eligible to receive immunotherapy\n\nExclusion Criteria:\n\nCohort A:\n\n⨀ Prior thoracic Radiotherapy\n\nCohort B:\n\n* Prior whole brain Radiotherapy\n* Prior surgical resection or focal radiotherapy of a target brain metastasis\n* Leptomeningeal disease\n\nCohort C:\n\n* Unresectable or metastatic (nodal or distant) disease\n* Synchronous malignancy requiring chemotherapy or other intensive treatment\n* Locally recurrent soft tissue sarcoma\n* Prior immunotherapy\n* Pregnancy or breastfeeding\n\nCohort D:\n\n* Distant metastasis\n* Inability to undergo PET-CT for baseline staging\n* HPV-positive or p16-positive oropharyngeal cancer\n* Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable\n* Prior immunotherapy for the study cancer or for a remote cancer\n* Prior head and neck radiotherapy",{"count":52,"type":21},105,[54],"PHASE1","To characterize feasibility, safety, and\u002For preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.",[57,29,58,59,60,61],"Small Cell Lung Cancer Extensive Stage","Solid Tumor, Adult","Thoracic Cancer","Sarcoma,Soft Tissue","HNPCC","2026-08-12",{"date":64,"type":34},"2026-08-17",{"date":66,"type":34},"2025-10-28",{"date":68,"type":21},"2032-09-01",{"name":70,"class":41},"University of Texas Southwestern Medical Center",1,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":71},"100368181","mri-biomarkers-for-radiation-induced-neurocognitive-decline-following-srs-of-newly-diagnosed-brain-mets-100368181","NCT04073966","MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets","Magnetic Resonance Imaging Biomarkers for Radiation-Induced Neurocognitive Decline Following Stereotactic Radiosurgery of Newly Diagnosed Brain Metastases: An Observational Pilot Study","Inclusion Criteria:\n\n* Histologic diagnosis of cancer\n* Newly diagnosed brain metastasis being treated with SRS. Any extent of cranial disease permitted. Subsequent courses of SRS while on study permitted when clinically indicated.\n* Patients are permitted to have undergone craniotomy and resection of metastasis\u002Fmetastases if at least 1 other intact metastasis planned for definitive SRS is present. Receiving or previously received systemic therapy also permitted.\n* Anticipated life expectancy at least 1 year\n* Age ≥ 18 years\n* Ability to read and comprehend written English and follow instructions in English\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Previous radiation to the brain or head\n* Previous malignancy - other than non-melanomatous skin cancer or cervical carcinoma in situ - and not disease-free for at least 3 years\n* Previous severe head or brain injury\n* History of a neurological disorder such as Epilepsy, Parkinson's, Alzheimer's, or Dementia\n* Prisoners",{"count":80,"type":21},20,"OBSERVATIONAL","Brain metastases are a source of much morbidity and mortality in adults with primary solid malignant tumors. With improvements in systemic therapy that prolong survival but have limited central nervous system penetration, patients with brain metastases are at increasing risk of developing and experiencing long-term side effects from treatment of brain metastases. The overarching goal of this study is to better understand the determinants of RT-associated changes in white and gray matter function and associated neurocognitive decline.",[29,84,85,86],"Neurocognitive Deficit","White Matter Alterations","Radiation Exposure",{"date":31,"type":34},{"date":89,"type":34},"2019-12-04",{"date":91,"type":21},"2029-05-31",{"name":93,"class":41},"UNC Lineberger Comprehensive Cancer Center",{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":71},"100612026","phase-2-memory-avoidance-whole-brain-radiotherapy-vs-hippocampal-avoidance-whole-brain-radiotherapy-athena-2-trial-100612026","NCT07248228","Memory Avoidance Whole Brain Radiotherapy vs Hippocampal Avoidance Whole Brain Radiotherapy (Athena 2 Trial)","A Randomized Phase 2 Trial of Memory Avoidance Whole Brain Radiotherapy Versus Hippocampal Avoidance Whole Brain Radiotherapy (Athena 2 Trial)","Inclusion Criteria:\n\n* Participants must have histologically, cytologically, or radiographically confirmed diagnosis of solid tumor with brain metastases\n* Age \\>18 years\n* Performance status: Karnofsky Performance Status (KPS) ≥ 70\n* Estimated life expectancy of at least 3 months\n* Participant must be considered a candidate for WBRT by the treating physician\n* Participant must be a primary English speaker and have the ability to understand and the willingness to sign an English written informed consent document\n* Participant has at least 10 brain metastases or is otherwise suitable for WBRT\n\nExclusion Criteria:\n\n* Prior whole brain radiation\n* Participant has Multiple Sclerosis, Alzheimer's, dementia, or mental disability\n* Pregnant or breastfeeding women are excluded from this study.\n* Participant is not able to receive an MRI\n* Participant has metastasis within avoidance neurocognitive substructures (hippocampus, amygdala, fornix, corpus callosum, pituitary, amygdala)",{"count":102,"type":21},90,[24],"Participants in this research study have cancer that has spread to their brain, called brain metastases. One treatment for this type of cancer is called whole brain radiotherapy that stays away from a specific neurocognitive substructure, called the hippocampus, combined with medication to preserve cognitive function. This study compares that approach to another approach of whole brain radiotherapy that stays away from additional structures that are thought to have a role in cognitive function. Researchers want to see if there is a difference in the preservation of cognitive function between these two approaches.",[29],[107,108,109],"Whole brain radiotherapy","Memory-avoidance whole brain radiotherapy","Hippocampal-avoidance whole brain radiotherapy","2026-08-04",{"date":112,"type":34},"2026-08-06",{"date":114,"type":34},"2026-07-09",{"date":116,"type":21},"2028-11",{"name":118,"class":41},"Case Comprehensive Cancer Center",{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":71},"100341498","phase-i-study-of-fractionated-stereotactic-radiation-therapy-100341498","NCT03726359","Phase I Study of Fractionated Stereotactic Radiation Therapy","Phase I TITE-CREM Dose Escalation Study of Fractionated Stereotactic Radiation Therapy (FSRT) in Unresected Brain Metastases","Inclusion Criteria:\n\n* Pathologically proven diagnosis of a non-hematological malignancy other than small cell lung cancer within 5 years of registration\n* Intact (unresected) brain metastases measuring ≥3 cm and ≤ 6 cm in largest dimension on gadolinium contrast enhanced MRI obtained within 30 days prior to registration OR Surgically resected brain metastasis for which postoperative stereotactic radiotherapy is indicated, with expected target measuring ≥3 cm and ≤6 cm in largest dimension\n* Prior Whole Brain Radiation Therapy (WBRT) is allowed\n* Age ≥ 18 years\n* Women of childbearing potential and male participants must practice adequate contraception\n* History\u002FPhysical examination within 30 days prior to registration\n* Life expectancy \\>3 months\n* Patients are allowed to enroll if previously treated to other lesions with Stereotactic Radiosurgery (SRS)\n* Patients with multiple lesions are allowed, as long there is one dominant lesion that will be treated with FSRT. Other lesions may be treated concurrently with SRS or FSRT at the discretion of the treating physician but will not contribute to the study endpoints\n\nExclusion Criteria:\n\n* Patients with definitive leptomeningeal metastases, based on cerebrospinal fluid (CSF) examination\n* Plan for chemotherapy or targeted agents during treatment. Hormonal therapy, immunotherapy targeting PD-1\u002FPD-L1 axis, and bone supportive therapy may be continued during treatment\n* Contraindication to enhanced MRI imaging such as implanted metal devices. However, patients with implanted devices which are MRI compatible are allowed\n* Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy\n* Uncontrolled intercurrent illness such as congestive heart failure, unstable angina, cardiac arrhythmia, and uncontrolled seizure activity\n* Previous treatment of the target lesion with radiotherapy",{"count":127,"type":21},43,[129],"NA","There is a lack of prospective trial data and consensus guidelines describing the use of Fractionated Stereotactic Radiation Therapy (FSRT) in the treatment of brain metastases. There has been no prospective dose escalation study performed to date to determine the maximum tolerated dose (MTD) in patients treated with FSRT. Prescription doses in the series described above ranged from 18 Gy to 42 Gy, delivered in 3 to 12 fractions. The results of this study will be used to plan future Phase II\u002FIII studies to determine the efficacy of different dose fractionation schedules of FSRT. The investigator team thus proposes a Phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.",[29],"2026-07-31",{"date":134,"type":34},"2026-08-03",{"date":136,"type":34},"2017-12-25",{"date":138,"type":21},"2027-06",{"name":140,"class":41},"Albert Einstein College of Medicine",{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":148,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":71},"100581953","trial-of-differential-margins-in-single-isocenter-radiosurgery-of-brain-metastases-100581953","NCT06857006","Trial of Differential Margins in Single Isocenter Radiosurgery of Brain Metastases","UAB 2507 - Randomized Phase II Study of Differential Margins in Single Isocenter Radiosurgery of Brain Metastases","Inclusion Criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Male or female, aged 19 and older\n3. Brain metastases diagnosis not requiring retreatment to the same tumor\n4. For females of reproductive potential should undergo pregnancy testing as per UAB Radiation Oncology standard policies\n5. Ability of subject or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Current use of cytotoxic chemotherapy within 3 days of treatment. There are no restrictions on the use of immunotherapy during treatment. TKIs known to be radiation sensitizers such as BRAF should be held at least 24 hours prior to treatment.\n2. Inability to have MRI imaging\n3. Pregnancy\n4. Treatment with another investigational drug 14 days of enrollment\n5. Radiosurgery planned for post-operative adjuvant cavity only. Patients with any gross residual after surgery are eligible. Patients with at least one intact metastasis may enroll but adjuvant cavity will not be evaluable.\n6. At the time of Radiation Oncology consultation more than twenty targets are identified. Note that it is common that a few additional metastases may be identified during the treatment planning or peer review processes. More than twenty targets may be included if this number is found after the initial clinical review of the treatment planning MRI.\n7. Tumor maximal diameter \\> 4 cm.\n8. Prior SBRT or SRS to a lesion planned for retreatment. Note that patients with prior whole brain radiation alone are eligible.\n9. Patients with diffuse leptomeningeal tumor are not eligible. Patients with a focal dural or pachymeningeal tumor are eligible if other intra-axial tumors are planned to be treated. Similar to postoperative cavities, the pachymeningeal tumor deposit will be treated but not evaluable for the assessment of local control or toxicity.\n\nINCLUSION OF VULNERABLE PARTICIPANTS Vulnerable populations as defined by the NIH including children, prisoners, and adult subjects who lack capacity to consent to research participation are not eligible.","19 Years",{"count":150,"type":21},180,[129],"Radiosurgery is the use of a focal high dose of radiation therapy to ablate or kill a tumor. This trial will enroll patients with brain metastases 4 cm or less in greatest diameter and will compare 0mm margin to a 2mm margin for treatment.",[29],[29,155,156,157,158],"stereotactic radiosurgery (SRS)","radiosurgery (RS)","edge linear accelerator","single isocenter radiosurgery","2026-07-28",{"date":161,"type":34},"2026-07-30",{"date":163,"type":34},"2025-04-08",{"date":165,"type":21},"2028-08",{"name":167,"class":41},"University of Alabama at Birmingham",{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":180,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100442789","phase-2-optimizing-neurocognition-with-whole-brain-radiation-therapy-wbrt-using-upfront-pulsed-reduced-dose-rate-prdr-technique-100442789","NCT05045950","Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique","Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases","Inclusion Criteria:\n\n1. Age ≥18 years at diagnosis of brain metastases.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Score of \\\u003C2.\n3. Participants must have a biopsy-proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either the primary or any metastatic site) with intracranial lesions radiographically consistent with or pathologically proven to be brain metastases.\n4. Patients who have undergone prior systemic therapy are eligible.\n5. Life expectancy from extracranial disease greater than six months.\n6. Patients with measurable brain metastasis.\n7. Patients may have had prior therapy for brain metastasis, including stereotactic radiosurgery (SRS)and surgical resection. Patients must have completed prior therapy by at least 7 days prior to study enrollment for SRS and at least 14 days for surgical resection\n8. If an open biopsy is performed, the patient must be at least one-week post-biopsy. This requirement is not necessary for stereotactic biopsies.\n9. Creatinine clearance is ≥ 30 mL\u002Fmin.\n10. Start of PRDR WBRT within two weeks following registration.\n11. Ability to complete the Neurocognitive Function (NCF) test battery (including people whose primary language is English).\n12. Patients with previous or other malignancies whose disease is controlled and not impacting ECOG performance or life expectancy.\n13. Willing and able to give consent and to comply with treatment and follow-up schedule.\n\nExclusion Criteria:\n\n1. Metastases from hematological malignancy, or central nervous system malignancy.\n2. Patients whose malignancy is being treated with curative intent.\n3. Leptomeningeal metastases.\n4. Contraindication to MRI imaging with contrast.\n5. Contraindication to memantine including concurrent use of N-methyl-D-aspartate (NMDA) antagonists.\n6. Stage IV-V chronic kidney disease or end-stage renal disease.\n7. Participants with a maximum tumor diameter exceeding 5 cm (if not resected).\n8. Prior cranial whole brain radiation therapy.\n9. Past medical history of dementia which is thought to be unrelated to the brain metastases.\n10. Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy.\n11. Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician, prevent informed consent or completion of protocol treatment, and\u002For follow-up visits.\n12. Non-native English speakers will be excluded since patients often lose their faculty with the language they acquired second before their native language is affected in the context of cognitive decline. This could adversely affect performance on verbal cognitive tasks.",{"count":176,"type":21},53,[24],"Study patients will receive Whole-brain radiation therapy (WBRT) - pulsed reduced dose rate (PRDR) within 14 days of registration. All patients will receive single daily fractions using 3D conformal radiotherapy. A dose of 30 Gy in 10 fractions will be delivered using the PRDR technique.",[29],[181,182],"whole-brain radiation therapy","upfront pulsed reduced dose-rate","2026-07-27",{"date":185,"type":34},"2026-07-29",{"date":187,"type":34},"2021-11-17",{"date":189,"type":21},"2029-05",{"name":191,"class":41},"Medical College of Wisconsin",2,{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":71},"100492476","phase-2-reducing-the-incidence-of-symptomatic-brain-metastases-with-mri-surveillance-100492476","NCT05692635","Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance","Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance in Non-Squamous Locally Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years of age.\n* Patients with non-squamous locally advanced lung cancer defined by American Joint Committee on Cancer (AJCC) version 8 stage IIIA, IIIB, or IIIC disease.\n* Histology described as adeno-squamous or not otherwise specified favoring squamous are eligible.\n* Patients may be enrolled before or after the start of radiation therapy but must be enrolled and have their first surveillance MRI brain at 120 +\u002F- 10 days of their first treatment of radiation therapy for their locally advanced lung cancer. The first radiation treatment is defined as day 1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.\n* Epidermal growth factor receptor (EGFR) \\> 30 mL\u002Fmin\u002F1.73m2.\n* Patients must be eligible for a brain MRI per the Wake Forest MRI safety screening checklist questionnaire. This will be completed by a MRI imaging technician, enrolling physician, CPDM staff member, a magnetic resonance safety officer, and\u002For a radiologist as indicated in the form.\n\nExclusion Criteria:\n\n* Known brain metastases on staging MRI.\n* Questionable findings that may represent a differential of vasculature abnormalities\u002Fstroke\u002F and or metastatic disease with recommended short interval follow-up are not an exclusion factor for study participation. The recommended follow-up imaging for such findings should have no bearing on the imaging schedule in this protocol, and this research protocol imaging should NOT serve as an official follow-up scan for such findings.\n* Patients who are pregnant or breastfeeding.\n* Premenopausal persons of childbearing potential must have a negative pregnancy test within 14 days of enrollment. If women are not of childbearing potential as defined by women who are menopausal female or has had a hysterectomy, bilateral oophorectomy, or medically-documented ovarian failure, they will not require a pregnancy test. 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.",{"count":201,"type":21},60,[24],"The purpose of this research is to see if monitoring the brain using magnetic resonance imaging (MRI) after radiation therapy will allow investigators to find cancer that has spread to the brain (brain metastases) before it causes symptoms.",[29,205],"Nonsmall Cell Lung Cancer Stage III","2026-07-16",{"date":208,"type":34},"2026-07-17",{"date":210,"type":34},"2023-08-30",{"date":212,"type":21},"2028-04",{"name":214,"class":41},"Wake Forest University Health Sciences",{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":71},"100491038","phase-2-a-phase-ii-study-of-tucatinib-and-ado-trastuzumab-emtansine-t-dm1-in-patients-with-her2-positive-metastatic-solid-tumors-and-metastases-to-brain-tucatemeb-100491038","NCT05673928","A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)","Inclusion Criteria:\n\n1. Histologically confirmed HER2-positive metastatic solid tumor. HER2 positivity defined as HER2 overexpression by immunohistochemistry (IHC) 3+ or 2+ and fluorescence in situ hybridization (FISH) positive and\u002For HER2 amplification by in situ hybridization (ISH) or next generation sequencing (NGS) and\u002For activating ERBB2 mutation(s) (verified by MDACC Precision Oncology Decision Support).\n2. Patients must have one of the following on the screening brain MRI:\n\n   * Untreated brain metastases not requiring immediate local CNS therapy\n   * Previously treated brain metastases with progression of previous lesions or new lesions, but not requiring immediate local CNS therapy\n   * At least one measurable untreated brain lesion ≥0.5 cm and \\\u003C3.0 cm in the longest axis\n   * Prior SRS radiosurgery (must be completed within 7 days of study treatment initiation) is allowed as long as the previous treatment volume does not overlap with the current targets.\n3. Measurable (per the RECIST v1.1) or evaluable extracranial disease.\n4. Prior treatment with HER2-targeted treatments such as trastuzumab, pertuzumab, T-DM1, neratinib, lapatinib, or tucatinib is allowed, but not required. Patients with breast and gastric cancer must have received at least 1 line of HER2 targeted treatment.\n5. Age ≥18 years at the time of consent.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Appendix B).\n7. Life expectancy ≥3 months, in the opinion of the investigator.\n8. Adequate hematological and end-organ function, defined by the following laboratory test results, obtained within 28 days prior to study treatment initiation:\n\n   * Absolute neutrophil count ≥1,200\u002FμL\n   * Platelet count ≥100,000\u002FμL\n   * Hemoglobin ≥9g\u002FdL\n   * Total bilirubin ≤1.5 × upper limit of normal (ULN), except for patients with known Gilbert's disease, who may enroll if conjugated bilirubin is ≤1.5 × ULN\n   * Transaminases (AST\u002FALT) ≤1.5 × ULN (≤5 × ULN if liver metastases are present)\n   * Creatinine level \\\u003C1.5 x ULN or estimated glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 using the Modification of Diet in Renal Disease (MDRD) study equation as applicable.\n9. International normalized ratio (INR) and partial thromboplastin time (PTT)\u002Factivated partial thromboplastin time (aPTT) ≤1.5 × ULN, unless on medication known to alter INR and PTT\u002FaPTT. Proprietary Information of MD Anderson Protocol 2021-0899 v.5.0,04\u002F24\u002F2023 28\n10. LVEF ≥50% as assessed by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan documented within 3weeks prior to study treatment initiation.\n11. For patients of childbearing potential, as defined in Section 4.3, the following stipulations apply:\n\n    * Must have a negative serum or urine pregnancy test (minimum sensitivity of 25 mIU\u002FmL or equivalent units of beta-human chorionic gonadotropin \\[β-hCG\\]) result within 3 days prior to study treatment initiation. A patient with a false positive result and documented verification that the patient is not pregnant will be eligible.\n    * Must agree not to try to become pregnant during the study and for at least 7 months after the final dose of study treatment\n    * Must agree not to breastfeed or donate ova starting at the time of informed consent and continuing through the study and for 7 months after the final dose of study treatment\n    * If sexually active in a way that could lead to pregnancy, must consistently use highly effective methods of birth control (i.e., methods that achieve a failure rate of \\\u003C1% per year when used consistently and correctly) starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment.\n\n    Highly effective methods of birth control include:\n\n    i. Intrauterine device ii. Bilateral tubal occlusion\u002Fligation iii. Vasectomized partner iv. Sexual abstinence when it is the preferred and usual lifestyle choice of the patient.\n12. For patients who can father children, the following stipulations apply:\n\n    * Must agree not to donate sperm starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment\n    * If sexually active with a person of childbearing potential in a way that could lead to pregnancy, must consistently use a barrier method of birth control starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment\n    * If sexually active with a person who is pregnant or breastfeeding, must consistently use a barrier method of birth control starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment.\n13. The patient must provide written informed consent.\n14. Must be willing to undergo biopsy as required by the study, if clinically considered safe and feasible by the investigator.\n\nExclusion Criteria:\n\n1. Patients must not have any of the following on the screening brain MRI:\n\n   * Any untreated brain lesions \\>3.0 cm in size\n   * Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to the patient (e.g., brainstem lesions). Patients who undergo local treatment for such lesions may still be eligible for the study based on inclusion criteria #2.\n2. Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \\>4 mg of dexamethasone (or equivalent).\n3. Poorly controlled (\\>1\u002Fweek) generalized or complex partial seizures, or manifestation of neurologic progression due to brain metastases notwithstanding CNS-directed therapy.\n4. History of allergic reactions to trastuzumab or compounds chemically or biologically similar to tucatinib, except for Grade 1 or 2 IRRs to trastuzumab that were successfully managed, or known allergy to any of the excipients in the study drugs.\n5. Treatment with any systemic anticancer therapy or investigational agent within 5 half-lives (of the drug) or within 21 days (whichever is shorter ) prior to study treatment initiation.\n6. Any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:\n\n   * Alopecia;\n   * Neuropathy, which must have resolved to ≤ Grade 2;\n   * Congestive heart failure (CHF), which must have been ≤ Grade 1 in severity at the time of occurrence and must have resolved completely.\n7. Clinically significant cardiopulmonary disease such as:\n\n   * Ventricular arrhythmia requiring therapy\n   * Symptomatic hypertension or uncontrolled asymptomatic hypertension as determined by the investigator\n   * Any history of symptomatic CHF, left ventricular systolic dysfunction, or decrease in LVEF\n   * Severe dyspnea at rest (National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] ≥ Grade 3) due to complications of advanced malignancy or hypoxia requiring supplementary oxygen therapy\n   * Grade 2 or greater corrected QT interval (QTc) prolongation on screening electrocardiogram (ECG).\n8. Known myocardial infarction or unstable angina within 6 months prior to study treatment initiation.\n9. Unable for any reason to undergo contrast MRI of the brain.\n10. Have used a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or a strong CYP3A4 or CYP2C8 inducer within 5 days prior to study treatment initiation. Concomitant use of strong CYP3A4 inducers or CYP2C8 inducers or inhibitors is also prohibited during study treatment and for 2 weeks after discontinuation of study treatment. Use Proprietary Information of MD Anderson of sensitive CYP3A substrates should be avoided 2 weeks prior to study treatment initiation and during study treatment.\n11. Known carrier of hepatitis B or hepatitis C virus or has other known chronic liver disease.\n12. Known positive human immunodeficiency virus status.\n13. Patients who are pregnant, breastfeeding, or planning to become pregnant from the time of informed consent until 7 months after the last dose of study treatment.\n14. Unable to swallow pills or has significant GI disease that would preclude adequate oral absorption of medication.\n15. Other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact patient safety or compliance with study procedures.\n16. Evidence within 1 year of the start of study treatment of another malignancy that required systemic treatment.\n17. Patients who are eligible for the HER2CLIMB-02 study (NCT03975647) and they can be enrolled in that study.",{"count":222,"type":21},30,[24],"To learn if the study drugs, tucatinib and adotrastuzumab emtansine (T-DM1), can help to control solid tumors that have spread to the brain.",[226,29],"Metastatic Solid Tumor","2026-07-15",{"date":206,"type":34},{"date":230,"type":34},"2023-05-16",{"date":232,"type":21},"2029-03-01",{"name":234,"class":41},"M.D. Anderson Cancer Center",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":253,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100646467","ctdna-guided-intraventricular-therapy-for-cns-malignancies-100646467","NCT07689721","ctDNA-Guided Intraventricular Therapy for CNS Malignancies","ctDNA-Guided Intraventricular Therapy Trial: A Prospective Study in Patients With Malignant Gliomas or Brain Metastases From Non-Small Cell Lung Cancer and Breast Cancer","GUIDE-CNS","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of histologically or cytologically confirmed HER2+ breast cancer, or triple negative breast cancer, or Stage IV non-small cell lung cancer, or recurrent high-grade glioma).\n* Undergoing clinically indicated cerebrospinal fluid (CSF) collection as part of routine clinical care: CSF may be obtained via lumbar puncture or existing CSF access device. Decision for CSF collection must be made independently by the treating clinical team and not solely for research purposes.\n* Detectable CSF ctDNA and\u002For positive CSF cytology, with consideration for CNS-directed management by the treating neuro-oncology team.\n* Ability to provide informed consent, or availability of a legally authorized representative (LAR).\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* Inability to provide informed consent and no legally authorized representative (LAR) available.\n* Not undergoing clinically indicated CSF collection as part of standard clinical care.\n* Absence of detectable CSF ctDNA and absence of positive CSF cytology.\n* Not being considered for CNS-directed management by the treating neuro-oncology team.\n* Clinical contraindications to CSF collection, including but not limited to: Significant intracranial mass effect; (e.g., midline shift \\>5 mm or effacement of basal cisterns); Obstructive hydrocephalus or posterior fossa mass effect; Coagulopathy or bleeding risk precluding lumbar puncture or CSF access; Inability to safely obtain CSF access.","120 Years",{"count":245,"type":21},77,[129],"This prospective, single-center study will evaluate whether cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) testing using the Belay Summit assay can improve the clinical management of patients with malignant gliomas or brain metastases from non-small cell lung cancer (NSCLC) or breast cancer who are suspected of having central nervous system (CNS) disease. Patients undergoing clinically indicated CSF evaluation will receive standard clinical testing, including CSF cytology and the Belay Summit ctDNA assay. Treatment decisions will remain at the discretion of the treating multidisciplinary neuro-oncology team. The primary objective is to evaluate 6-month clinical CNS progression-free survival (cCNS-PFS), with secondary objectives assessing safety and the association between CSF ctDNA dynamics and clinical outcomes. Exploratory proteogenomic analyses will be performed on residual CSF specimens when sufficient sample is available.",[249,250,29,251,252],"Leptomeningeal Disease","Glioblastoma","Non-Small Cell Lung Cancer","Breast Cancer","NOT_YET_RECRUITING","2026-07-01",{"date":256,"type":34},"2026-07-08",{"date":258,"type":21},"2027-01-01",{"date":260,"type":21},"2032-01-01",{"name":262,"class":41},"Alireza Mansouri",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":71},"100239086","phase-1-stereotactic-radiosurgery-dose-escalation-for-brain-metastases-100239086","NCT02390518","Stereotactic Radiosurgery Dose Escalation for Brain Metastases","Phase I Study of Stereotactic Radiosurgery Dose Escalation for Brain Metastases","Inclusion Criteria:\n\n* Clinically confirmed brain metastases by CT or MRI criteria. If there is evidence of extra-cranial metastatic disease, it is preferable that the lesions be pathologically confirmed (see section 4.2.5 for excluded histologies) and reviewed by a University of Utah or Huntsman Cancer Hospital pathologist if the initial review was done at an outside facility.\n* Prior brain surgery is allowed, although a lesion situated in the operative bed would not be selected to receive an experimental dose of SRS treatment. SRS should be delivered 4-6 weeks post-surgery if the patient had a craniotomy for resection of a lesion. Enrollment of a patient with the goal of performing SRS outside of the 4-6 post-craniotomy window is at the PI's discretion.\n* Patients must have 1-5 untreated brain metastases total.\n* For patients planning to enroll in Cohort 1a (including expansion) or Cohort 1b: Tumor volume ≤ 4.1888 cm3 by CT or MRI measurement at the time of consultation\u002Fscreening for the metastatic lesion on trial. Patients who have at least one additional lesion that is larger than the lesions eligible for the expansion cohort, but who are unable to find another open cohort, will have the eligible lesion(s) treated in the expansion cohort, and the remaining lesion(s) treated at the standard dose.\n\n  * For patients enrolling in the expansion Cohort 1a: Up to five brain metastases with tumor volume ≤ 0.5237 cm3 by CT or MRI measurement at the time of consultation\u002Fscreening will be treated on trial with the MTD. Brain metastases with volume \\> 0.5237 cm3 will be treated by standard of care SRS dosing.\n  * For patients enrolling in Cohort 1b: Tumor volume of \\> 0.5237 cm3 and ≤ 4.1888 cm3 by CT or MRI measurement at the time of consultation\u002Fscreening for the metastatic lesion on trial. All other brain metastases will be treated by standard of care SRS dosing.\n* As of Protocol Version 9, Cohorts 2 and 3 are permanently closed to accrual. For patients planning to enroll in Cohort 2 or 3: Equivalent tumor diameter ≤ 40 mm by CT or MRI measurement at the time of consultation\u002Fscreening for the metastatic lesion on trial. Equivalent tumor diameter \\\u003C\u002F=40 mm by CT or MRI measurement for all lesions treated by standard of care SRS dosing.\n* All metastatic lesions must be separated by a minimum of 3 cm as measured from the peripheral edges of the lesions that are in closest proximity to one another. If multiple lesions are present and are not all ≥ 3 cm away from each other, the patient will be deemed ineligible.\n* Prior systemic therapy is allowed, although appropriate washout is required for patients who have been on BRAF inhibitors (at least 7 days).\n* For subjects currently on active systemic cancer therapy, the treating medical oncologist should be consulted to ensure proper washout (if appropriate) periods prior to SRS.\n* Patients must be at least 18 years of age.\n* Karnofsky Performance Status (KPS) ≥ 60.\n* Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.\n* Women of child-bearing potential must have a negative pregnancy test within 10 days of study enrollment and must agree to use an acceptable method of birth control while receiving radiation and for 3 months after radiation. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for \\>1 year.\n* Men who are able to father a child must agree to use an acceptable method of birth control while receiving radiation, and for 3 months after radiation.\n\nExclusion Criteria:\n\n* Prior whole brain irradiation.\n* Brain lesions with an equivalent diameter of \\> 40 mm in size on MRI imaging at the time of consultation\u002Fscreening for protocol eligibility.\n* Lesions located in anatomic regions that are not amendable to SRS (e.g., optic nerve)\n* Brain lesions located in the brain stem.\n* Radiographic or cytologic evidence of leptomeningeal disease\n* Primary lesion with radiosensitive histology that includes the following: small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma\n* Women of child-bearing potential who are pregnant or breast feeding\n* Patients with multiple lesions, which by size criteria would be enrolled in a cohort that is full at the time of enrollment and the 12-16 weeks DLT period has not yet been reached.",{"count":5,"type":21},[54],"This is a Phase I dose escalation and expansion trial. The purpose of this study is to determine the maximum tolerated dose of radiation received during stereotactic radiosurgery in patients with brain metastases who have never received radiation to the brain before.",[29],"2026-06-30",{"date":276,"type":34},"2026-07-02",{"date":278,"type":34},"2015-05-07",{"date":280,"type":21},"2029-10",{"name":282,"class":41},"University of Utah",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":300,"leadSponsor":301,"locationsCount":303},"100563762","phase-2-ex-vivo-drug-response-evaluation-for-next-generation-care-of-brain-metastases-100563762","NCT06620380","Ex Vivo Drug Response Evaluation for Next Generation Care of Brain Metastases","EViDENCE-BM","Inclusion Criteria:\n\n* Patients must be 18 years or older on the day of signing the informed consent, female or male.\n* Patients must have a Karnofsky performance status of 60 or more\n* Patients must have limited systemic therapeutic options as per treating physician judgement. The number of previous lines of therapies is not limited.\n* Patients with a tumor with a targetable oncogenic driver mutation should have already been treated with a targeted agent and options must have been exhausted.\n* Patients must have a clinical indication for surgery for probable brain metastasis\n* Patients will be considered eligible for the study only if the diagnosis of brain metastasis has been histologically confirmed on the sample obtained during the surgery performed after signing the informed consent form for the trial.\n* Any type of primary cancer is allowed: breast cancer, lung cancer, melanoma, other cancers. Patients may have several primary cancers.\n* Patients must have adequate bone marrow, renal and hepatic function documented at screening before surgery\n* Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test\n* Patients must have the ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.\n* Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.\n\nExclusion Criteria:\n\n* Patients with rapidly progressive systemic disease\n* Patients with inability to undergo brain MRI evaluation.\n* Patients with progressive parenchymal brain metastases with an indication for requiring whole brain radiotherapy after surgery. Focal brain radiotherapy after surgery is allowed.\n* Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.\n* Intention to become pregnant during the course of the study.\n* Female who are pregnant.\n* Female who are breastfeeding and who do not agree to discontinue nursing prior to the first treatment initiated during the study.\n* Sexually active males and females of childbearing potential who are not willing to use an effective contraceptive method during the study. Male participants who do not agree not to donate sperm.",{"count":291,"type":21},102,[24],"Pharmacoscopy refers to an ex vivo real-time drug sensitivity profiling platform that has been shown to be of value in the treatment of leukemia (Snijder et al. 2017) (Kornauth et al. 2022) and may help to identify novel treatment opportunities for brain tumors as well (Lee et al. 2022). The rationale for pharmacoscopy-based drug sensitivity testing on real-time patient biopsies or surgery material is multiple: measuring drug response and sensitivity directly in real-time patient material, overcomes the problem of limited molecular biomarkers for established targeted therapeutic options and can identify effective drugs even for non-targeted therapies such as chemotherapy. It can also identify hitherto unknown specific vulnerabilities of cancer cells. Furthermore, testing directly on patient material overcomes the limitations of patient-derived cell cultures, organoids, and patient xenografts, as their prolonged culture times risk cellular adaptations and clonal selection that alter drug sensitivity. Pharmacoscopy maintains the tumor cell composition, including bystander cells or tumor microenvironment, and limits cell culture to max 48 hours. Furthermore, pharmacoscopy measures drug responses on a single-cell and on a high-content level, uniquely allowing to measure the drug sensitivity of tumor cells, and allowing to compare it to the drug cytotoxicity on healthy cells from the same patient. This relative readout has previously been shown to be essential for the correct prediction of a clinical response in haematological malignancies (Snijder et al. 2017) (Kornauth et al. 2022).\n\nThe aim of this study is to generate preliminary data regarding superiority of the personalized pharmacoscopy-guided approach compared to a standard non-pharmacoscopy-guided approach, in patients with brain metastases with an indication for surgery, and limited therapeutic systemic options according to the treating physician.",[29,295],"Brain Metastases, Adult","2026-06-25",{"date":298,"type":34},"2026-06-29",{"date":36,"type":34},{"date":138,"type":21},{"name":302,"class":41},"University of Zurich",3,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":318,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":333},"100448857","remaster-recurrent-brain-metastases-after-srs-trial-100448857","NCT05124912","REMASTer: REcurrent Brain Metastases After SRS Trial","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Patients with radiographically proven (by gadolinium-enhanced \\[Gd-\\] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer.\n2. Patients with a \"targetable\", bidimensionally-measurable, intracranial lesion that is radiographically recurrent after previous treatment with SRS +\u002F- surgery (craniotomy or LITT). To classify a lesion as radiographically progressive, the lesion must demonstrate a ≥ 25% increase in size following treatment based on the Neuro-Oncology Criteria of Tumor Response for CNS Tumors. To be \"targetable\" for this study, the lesion should be coverable through a planned single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. An intra-operative decision to utilize two trajectories is acceptable and patient may remain on study.\n3. Patient must be at least 3 months post initial SRS treatment of the target lesion\n4. Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon.\n5. Frozen pathology diagnosis must be attainable.\n6. Patient must be symptomatically stable for a minimum of 3 days prior to the procedure date on a on a max total daily steroid dose equivalent to 4mg of Dexamethasone.\n7. ≥18 years of age\n8. KPS ≥70\n9. Patient is able and willing to complete study requirements\n10. Patients with adequate hematologic parameters (all tests to be performed within \\\u003C4 weeks of biopsy):\n\n    1. ANC ≥ 1.5 X 109\u002FL\n    2. Platelet count ≥ 100 x 109\u002FL\n11. Blood chemistry laboratory value for serum creatinine \\\u003C 1.5 x ULN (test to be performed within \\\u003C4 weeks of biopsy)\n12. Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and\u002For hysterectomy or to those patients who are postmenopausal)\n13. All patients of reproductive potential must agree to use an effective method of contraception during the study\n14. Patients must be accessible for follow-up\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Patients with greater than 3 progressing lesions at time of enrollment. To classify as a radiographically progressive, lesion must demonstrate a ≥ 25% increase in size following treatment based on the RANO criteria. Of note, there is no exclusion for total number of metastases. However, only one lesion can be selected to be the targeted lesion and this lesion alone may be ablated during the study procedure.\n2. Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches.\n3. Prior bevacizumab use within 4 weeks of study initiation\n4. Patients with additional concurrent malignancies requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix\n5. Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to complete the protocol related QOL questionnaires and cognition assessments\n6. Inability to tolerate or contraindication to steroid therapy (i.e., dexamethasone)\n7. Deemed ineligible or unable to tolerate SRS therapy by treating neurosurgeon and\u002For radiation oncologist\n8. Patients with any condition that would prohibit them from undergoing a surgical procedure, at the discretion of the treating physician team\n9. Patients unwilling or unable to give consent for participation\n10. Patients unable to comply with study requirements\n11. Patients with diffuse leptomeningeal disease\n12. Patients with rapidly progressing extracranial disease",{"count":311,"type":21},261,[129],"Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.",[29,315,316,317],"Radiation Necrosis","Recurrent Tumor","Recurrent Metastases",[319,320,321,322,315,29],"Laser Interstitial Thermal Therapy","Stereotactic Radiosurgry","LITT","SRS","2026-06-17",{"date":325,"type":34},"2026-06-18",{"date":327,"type":34},"2022-05-10",{"date":329,"type":21},"2028-10",{"name":331,"class":332},"Monteris Medical","INDUSTRY",9,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":377,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":405},"100499720","phase-1-phase-12-trial-of-s241656-in-selected-rasmapk-mutation--positive-malignancies-100499720","NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.",{"count":342,"type":21},554,[54,24],"BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.",[346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,29,370,371,372,373,374,375,376],"Non-small Cell Lung Cancer","Histiocytic Neoplasm","Histiocytosis","BRAF Gene Mutation","BRAF V600E","BRAF V600 Mutation","BRAF Mutation-Related Tumors","BRAF","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Lung Cancer","Recurrent Lung Cancer","Recurrent Lung Non-Small Cell Carcinoma","NSCLC","Solid Tumor","Solid Carcinoma","KRAS G12D","KRAS G12V","KRAS Mutation-Related Tumors","NRAS Gene Mutation","Thyroid Cancer","Thyroid Carcinoma","Colorectal Cancer","Colorectal Carcinoma","Recurrent Histiocytic and Dendritic Cell Neoplasm","Recurrent NSCLC","KRAS G13C","Acquired Resistance to KRAS G12C Inhibitor","KRAS G12A","KRAS G12F","KRAS G12R","KRAS G13D",[378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396],"BRAF Class I","BRAF Class II","BRAF Class III","KRAS","Intolerant histiocytic neoplasm","BDTX-4933","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions","2026-06-16",{"date":323,"type":34},{"date":400,"type":34},"2023-04-18",{"date":402,"type":21},"2028-06",{"name":404,"class":41},"Institut de Recherches Internationales Servier",27,{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":429,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":435,"locationsCount":192},"100431578","phase-2-stereotactic-brain-directed-radiation-with-or-without-aguix-gadolinium-based-nanoparticles-in-brain-metastases-100431578","NCT04899908","Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases","A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone","Inclusion Criteria:\n\n* Participants must have a biopsy proven solid malignancy and at least one intracranial measurable lesion spanning ≥5mm in maximal unidimensional size and radiographically consistent with or pathologically proven to be a brain metastasis AND meet one of the following additional criteria regarding the primary site or nature of the intracranial disease:\n\n  * Melanoma with intracranial growth consistent with tumor progression despite immunotherapy\n  * Gastrointestinal primary\n  * HER2 positive breast cancer (subtype assessed using most representative tissue available in opinion of enrolling clinician and\u002For study PI)\n  * Cystic metastases\n  * Metastases ≥2cm in maximal unidimensional size\n  * Locally recurrent metastases after prior stereotactic radiation\n  * Locally recurrent metastases after prior whole brain radiation \\*Patients with metastases from melanoma, GI primaries, or HER2+ breast cancer, as well as those with cystic metastases or metastases ≥2cm in maximal unidimensional size, who have local recurrences after prior brain-directed radiation can only be treated in the strata permitting prior radiation (last two strata above)\n* Age ≥18 years at diagnosis of brain metastases\n* Estimated glomerular filtration rate of ≥ 60 mL\u002Fmin\u002F1.73m2\n* Karnofsky performance status of at least 70 (i.e. at minimum, \"cares for self\" but \"unable to carry on normal activity or do active work\")\n* Estimated survival based on extracranial disease of at least 3 months in the opinion of the enrolling clinician and\u002For study PI\n* Ability to understand and the willingness to sign a written informed consent document\n* The effects of AGuIX on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the therapeutic component of study participation\n\nExclusion Criteria:\n\n* Participants who cannot undergo a brain MRI\n* Participants who cannot receive gadolinium\n* Participants with widespread, definitive leptomeningeal disease\n* Patients requiring radiation to either \\>10 targets (if naïve to whole brain radiation) or \\>20 targets (if whole brain radiation has been given previously) per the discretion of the treating clinician and\u002For study PI\n* Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study\n* In cohorts who have received prior brain-directed radiation, patients are not eligible for this study if they have active (at the time of protocol screening) brain metastases that require radiation that are in or within 1.0cm of the brainstem, eyes, optic nerves, or optic chiasm if the juxtaposed organ at risk (i.e. brainstem, eyes, optic nerves, or optic chiasm) has previously received either \\>6.0 Gy in a single fraction or, if prior radiation was fractionated, a cumulative dose in 2.0 Gy equivalents, using an alpha\u002Fbeta ratio of 2, of \\>40.0 Gy. In addition, all patients who have had prior brain-directed radiation, regardless of technique\u002Fdose\u002Ffractionation, are not eligible for the study until written approval is provided by the study\u002Fsite PI",{"count":414,"type":21},134,[24],"The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone.",[418,29,419,27,252,420,367,421,322,422,423,424,425,426,427,428],"Brain Cancer","Melanoma","HER2-positive Breast Cancer","Gastrointestinal Cancer","SRT","Whole Brain Radiation","Stereotactic Radiation","AGuIX","Nanoparticle","Cystic","Brain Tumor",[418,29,419,27,252,420,367,421,322,422,430,424,425,426,427,428],"Whole brain radiation",{"date":323,"type":34},{"date":433,"type":34},"2021-09-15",{"date":189,"type":21},{"name":436,"class":41},"Brigham and Women's Hospital",{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":452,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":469},"100471453","phase-2-a-study-of-stereotactic-radiosurgery-srs-for-people-with-lung-cancer-that-has-spread-to-the-brain-100471453","NCT05419076","A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain","A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Histologic diagnosis of small cell lung cancer\n* Radiographic diagnosis of up to 20 brain metastases on contrast-enhanced MRI\n* Age 18 and above\n* Performance status KPS 60-100\u002FECOG 0-2\n* Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment\n* The patient or legally authorized representative is able to provide informed consent\n\nExclusion Criteria:\n\n* Unable to undergo contrast-enhanced MRI brain\n* Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine\n* Pregnant or lactating women\n* Prior brain-directed radiotherapy\n* Uncontrolled systemic disease without reasonable systemic therapy options felt likely to result in death as observed on CT or PET\u002FCT imaging, no more than 3 months before study enrollment",{"count":445,"type":21},62,[24],"The purpose of the study is to see if stereotactic radiosurgery\u002FSRS is an effective treatment for people with a new diagnosis of brain metastases from small cell lung cancer\u002FSCLC.",[27,449,29,295,450,451],"Lung Cancer Metastatic","Small-cell Lung Cancer","Small Cell Lung Carcinoma",[453,454,455,456,457,458,459,460],"Stereotactic Radiosurgery","small cell lung cancer","small cell lung carcinoma","lung cancer","lung cancer metastatic","brain metastases","22-133","Memorial Sloan Kettering Cancer Center","2026-06-09",{"date":463,"type":34},"2026-06-10",{"date":465,"type":34},"2022-06-10",{"date":467,"type":21},"2027-06-10",{"name":460,"class":41},7,{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":479,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":5},"100327995","phase-3-stereotactic-radiosurgery-compared-with-hippocampal-avoidant-whole-brain-radiotherapy-ha-wbrt-plus-memantine-for-5-or-more-brain-metastases-100327995","NCT03550391","Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases","A Phase III Trial of Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases","Inclusion Criteria:\n\n* Patients must have 5 or more brain metastases as counted on a T1 contrast enhanced MRI obtained ≤ 30 days from randomization (maximum 15 brain metastases).\n* Patients must have a pathological diagnosis (cytological or histological) of a non-hematopoietic malignancy.\n* The largest brain metastasis must measure \\\u003C2.5 cm in maximal diameter.\n* Centre must have the ability to treat patients with either a Gamma Knife, Cyberknife, or a linear accelerator-based radiosurgery system.\n* Patient must be \\> 18 years of age.\n* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French either alone or with assistance.\n* ECOG performance status 0, 1, or 2.\n* Creatinine clearance must be ≥ 30 ml\u002Fmin within 28 days prior to registration.\n* The Neurocognitive Testing examiner must have credentialing confirming completion of the neurocognitive testing training.\n* Facility is credentialed by IROC to perform SRS and HA-WBRT. The treating centre must have completed stereotactic radiosurgery credentialing of the specific system(s) to be used in study patients. The treating centre must have completed IMRT credintialing of this specific IMRT systems to be used in study patients for the purposes of HA-WBRT.\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.\n* A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.\n* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 14 days of patient enrolment.\n* Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion Criteria:\n\n* Pregnant or nursing women.\n* Men or women of childbearing potential who are unwilling to employ adequate contraception.\n* Inability to complete a brain MRI.\n* Known allergy to gadolinium.\n* Prior cranial radiation therapy.\n* Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or HA-WBRT.\n* Primary germ cell tumour, small cell carcinoma, or lymphoma.\n* Widespread definitive leptomeningeal metastasis. This includes cranial nerve palsy, leptomeningeal carcinomatosis, ependymal involvement, cranial nerve involvement on imaging, suspicious linear meningeal enhancement, or cerebrospinal fluid (CSF) positive for tumour cells.\n* A brain metastasis that is located ≤ 5 mm of the optic chiasm or either optic nerve.\n* Surgical resection of a brain metastasis (stereotactic biopsies will be allowed).\n* More than 15 brain metastases on a volumetric T1 contrast MRI (voxels of 1mm or smaller) performed within the past 14 days, or more than 10 metastases in the case of a non-volumetric MRI.\n* Prior allergic reaction to memantine.\n* Current alcohol or drug abuse.\n* Current use of NMDA antagonists, such as amantadine, ketamine, or dextromethorphan.\n* Diagnosis of chronic liver disease\u002Fcirrhosis of the liver (e.g. Child-Pugh class B or C).\n* Patients with architectural distortion of lateral ventricular systems, which, in the opinion of the local investigator, makes hippocampal delineation challenging",{"count":478,"type":21},206,[480],"PHASE3","Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain.\n\nWhole brain radiation therapy with hippocampal avoidance (HA-WBRT) is when radiation therapy is given to the whole brain, while trying to decrease the amount of radiation that is delivered to the area of the hippocampus. The hippocampus is a brain structure that is important for memory. Memantine is a drug that is given to help relieve symptoms that can be caused by WBRT, including problems with memory and other mental symptoms.\n\nHealth Canada, the regulatory body that oversees the use of drugs in Canada, has not approved the sale or use of memantine in combination with WBRT to treat this kind of cancer, although they have allowed its use in this study.",[29],"2026-06-08",{"date":461,"type":34},{"date":486,"type":34},"2018-11-22",{"date":488,"type":21},"2027-12-31",{"name":490,"class":491},"Canadian Cancer Trials Group","NETWORK",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":71},"100643397","early-18f-fdg-pet-dynamic-analysis-in-brain-metastases-after-radiotherapy-100643397","NCT07632092","Early [18F]-FDG PET Dynamic Analysis in Brain Metastases After Radiotherapy.","Interest of Early Dynamic Analysis of [18F]-FDG PET Images in the Differential Diagnosis Between Recurrence and Radionecrosis in Brain Metastases.","DYNFDGTEP","Inclusion Criteria:\n\n* Patient referred for cerebral \\[18F\\]-FDG PET examination prescribed as part of his usual medical care for brain metastasis.\n* Age ≥ 18 years old\n* Affiliation to a social security program\n* Ability of the subject to understand and express his consent\n\nExclusion Criteria:\n\n* Age under 18 years old\n* Person under guardianship or curatorship\n* Pregnant or breastfeeding woman\n* Primary brain tumors\n* Brain metastases from renal, thyroid or other cancers known to have low avidity for \\[18F\\]-FDG",{"count":501,"type":21},50,"Various treatment options are available for brain metastases, depending on factors such as lesion site or number lesions. Radiotherapy is a commonly used treatment. Following stereotactic radiotherapy for brain metastases, a potential complication, namely brain radionecrosis, can occur subsequently. It is essential to differentiate between this radionecrosis and lesion recurrence in order to determine the appropriate treatment approach. Contrast-enhanced magnetic resonance imaging (MRI) is the most widely used technique for monitoring brain metastases. Therefore, patients undergo routine MRI at 3 months and during subsequent follow-ups, but if the lesion evolve and if distinguishing between recurrence and radionecrosis is challenging, an \\[18F\\]-FDG PET scan is then prescribed by oncologists or radiotherapists during follow-up consultations. As part of the standard patient management protocol, a 10-minute image acquisition begins after a 45-60 minutes wait following the radiotracer injection. A second image acquisition is then conducted 3-4 hours later. For both acquisitions, a low-dose X-ray scanner is synchronously coupled to allow attenuation correction of the PET images.\n\nPatient for whom a \\[18F\\]-FDG PET cerebral examination has been prescribed as part of the usual management of brain metastases will be eligible to the protocol. If the patient agrees to participate, an early imaging session is initiated immediately upon radiotracer injection, lasting 15 minutes in addition to the standard acquisition protocol.",[504,29,315],"Short Time Examination",[506,504,29,315],"18F]-FDG PET","2026-06-02",{"date":483,"type":34},{"date":510,"type":34},"2026-05-18",{"date":512,"type":21},"2028-11-18",{"name":514,"class":41},"Centre Hospitalier Universitaire, Amiens",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":71},"100596369","medex-no-perioperative-dexamethasone-in-brain-metastases-100596369","NCT07044557","MeDex: No Perioperative Dexamethasone in Brain Metastases","Inclusion Criteria:\n\n1. New brain tumor(s) on imaging\n2. Visceral mass(es) suspicious or confirmed for neoplasm\n\n   a. Patients with lung mass suspicious for primary lung cancer and no prior diagnosis must undergo biopsy of the lung mass prior to resection of brain metastasis(es) to exclude histology (i.e., small cell lung carcinoma) that would not benefit from resection\n3. No contraindications for craniotomy\n4. Age ≥ 18 years\n5. ECOG performance status ≤ 2 (i.e., ambulatory \\> 50% of waking hours)\n6. Midline shift on MRI ≤ 10 mm\n7. Craniotomy planned to resect \\>75% of the enhancing mass (surgeon's judgment)\n\nExclusion Criteria:\n\n1. Presence of BMs not eligible for resection that are each \\> 2 cm in any one dimension\n2. \\>4 BMs not eligible for resection that are each 2 cm in any one dimension\n3. Treatment with laser interstitial thermal therapy (LITT)\n4. High concern for primary CNS lymphoma\n5. Diagnosis of small cell lung carcinoma\n6. Any receipt of Dex\n7. Steroid use in the past month\n8. A condition that requires steroids\n9. Stage 4 chronic kidney disease (GFR\\\u003C30)\n10. Pregnant or breastfeeding",{"count":522,"type":21},35,[129],"Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).",[29],"2026-05-28",{"date":528,"type":34},"2026-05-29",{"date":530,"type":21},"2026-08-01",{"date":532,"type":21},"2027-10",{"name":534,"class":41},"University of Louisville",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":547,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":71},"100519787","phase-1-18f-fluciclovine-pet-amino-acid-evaluation-of-brain-metastasis-treated-with-stereotactic-radiosurgery-100519787","NCT06048094","18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery","18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)","FACILITATE","Inclusion Criteria:\n\n* Diagnosis of cancer with radiographic finding of brain metastasis\n* Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension\n* Planned treatment with SRS as per the treating physician team\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET\n\nExclusion Criteria:\n\n* Prior anaphylactic reaction to 18F-fluciclovine\n* Radiographic evidence of leptomeningeal disease\n* Prior whole-brain radiation therapy\n* Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)\n* Pregnant or positive serum pregnancy test within 14 days of registration\n* Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed.\n* Major medical illness or psychiatric\u002Fcognitive impairments, which in the investigator's opinion, will prevent completion of protocol and\u002For preclude informed consent\\*\n\n  * A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.",{"count":20,"type":21},[54],"This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.",[29,295,418],[548,549,550],"stereotactic radiosurgery","18F-flucicloivine","PET imaging",{"date":552,"type":34},"2026-05-20",{"date":554,"type":34},"2024-04-11",{"date":556,"type":21},"2033-05",{"name":558,"class":41},"Baptist Health South Florida",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":568,"conditions":569,"keywords":570,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":71},"100570875","phase-2-trial-of-relatlimab-nivolumab-and-ipilimumab-in-patients-with-asymptomatic-and-symptomatic-melanoma-brain-metastases-100570875","NCT06712927","Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases","A Multicenter, Phase II Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases","Inclusion Criteria:\n\n1. Histologically confirmed non-uveal melanoma that has metastasized to the brain. At least 1 measurable intracranial target lesion (5-40mm) which was not previously treated with local therapy (no prior SRS to this lesion). Prior surgery for a brain metastasis is allowed but this lesion cannot be a target lesion.\n\n   a. Growth or change in a lesion previously irradiated will not be considered measurable. Regrowth in cavity of previously excised lesion will not be considered measurable.\n2. Age ≥ 18 years\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 for Cohort A (asymptomatic), ECOG performance status 0-2 for Cohort B (symptomatic)\n4. No prior anti-CTLA-4, anti-PD-1, or anti-LAG-3 therapy for unresectable stage III\u002FIV melanoma. Prior CTLA-4, PD-1, and\u002For LAG-3 therapy in the neoadjuvant or adjuvant setting is acceptable if \\>6 months since last treatment. Participants may have had prior BRAF+MEK inhibitors for adjuvant therapy and\u002For unresectable\u002Fmetastatic melanoma if \\>2 weeks have elapsed since last treatment.\n5. Adequate organ function as assessed by the following parameters:\n\n   1. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (≤ 3 ×ULN); patients with liver metastasis ≤ 5 × ULN\n   2. Estimated creatinine clearance (eCrCl) ≥ 30 mL\u002Fmin using the Cockcroft-Gault formula at Screening\n   3. Total bilirubin ≤ 1.5x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\>1.5x ULN\n6. Patients must have recovered from all prior anti-cancer therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] v 5.0), except for alopecia, vitiligo, thyroid dysfunction, hypophysitis, or adrenal insufficiency, prior to enrollment.\n7. Cohort A (asymptomatic): participants must be free of neurologic signs and symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy greater than physiologic replacement (\\>10 mg of prednisone\u002Fday or equivalent) in the 10 days prior to beginning protocol therapy. Cohort B (symptomatic): participants may be on steroids with doses no higher than a total daily dose of 4 mg of dexamethasone or equivalent that is stable or tapering within 10 days prior to treatment. Patients who are symptomatic and are not being treated with steroids are also eligible.\n8. Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to treatment.\n9. Participants with a known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have been treated and cured. Participants with HBV or HCV infection who are currently on treatment must have an undetectable HCV viral load prior to treatment.\n10. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) OR at least 4 unstained slides, with an associated pathology report, for testing of tumor PD-L1 expression:\n\n    1. Tumor tissue should be of good quality based on total and viable tumor content.\n    2. Patients who do not have tissue specimens may undergo a biopsy during the screening period. Acceptable samples include core-needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Fine Needle Aspirations (FNA) will not be considered acceptable for tissue procurement.\n    3. Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable.\n    4. However, if repeat biopsy is not feasible, and no archival tissue available patient still may be enrolled.\n11. Any radiation treatment or excision of non-target brain lesions must have occurred ≥ 1 weeks before the start of dosing for this study. NOTE: The radiation field must not have included the brain index lesion(s).\n12. Radiation to non-CNS lesions is allowed and does not require a washout period for treatment initiation. Any radiation-related toxicity must have recovered to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] v 5.0).\n13. Women of child-bearing potential (WOCBP) must not be breastfeeding and must have a negative pregnancy test within 3 days prior to initiation of dosing. WOCBP (or female partners of male participants) must agree to use an acceptable method of birth control from the time of the negative pregnancy test, through the duration of treatment with the study combination and for 12 months after their last dose of any study component medication.\n\n    NOTE: A female participant is eligible to participate if she is not a woman of childbearing potential.\n\n    Approved methods of birth control are as follows:\n\n    Combined (estrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable Intrauterine device (IUD) Intrauterine hormone-releasing system (IUS) Bilateral tubal occlusion Vasectomized partner True sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) is not acceptable\n14. Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC) and agree to abide by the study restrictions and return to the site for the required assessments.\n\nExclusion Criteria\n\n1. Another primary malignancy within the previous 3 years (with the exception of carcinoma in situ of the breast, cervix, or bladder; localized prostate cancer; and non-melanoma skin cancer that has been adequately treated).\n2. Active medical illness(es) that would pose increased risk for study participation, including: active systemic infections (including COVID-19), coagulation disorders, or other major active medical illnesses of the cardiovascular, respiratory, or immune systems.\n3. Active autoimmune disease that has required systemic therapy with corticosteroids or other immunosuppressive agents within the past 3 years (excluding immune-related adverse events from immunotherapy as described above.\n4. Implanted device that precludes the use of MRI.\n5. Prior Grade 4 treatment-related AE with immune checkpoint inhibitor treatment.\n6. History of leptomeningeal metastasis determined by imaging or lumbar puncture.\n7. Prior whole brain radiation therapy (WBRT)\n8. Women who are breast-feeding or pregnant\n9. History of clinically significant cardiac disease or congestive heart failure \\> New York Heart Association (NYHA) class 2. Subjects must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months or a history of myocarditis\n10. Troponin T (TnT) or I (TnI) \\> 2 × institutional ULN. Participants with TnT or TnI levels between \\> 1 to 2 × ULN will be permitted if repeat levels within 24 hours are ≤ 1 ULN. If TnT or TnI levels are between \\>1 to 2 × ULN within 24 hours, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C 2 × ULN, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. Notification of the decision to enroll the participant following cardiologist recommendation has to be made to the principal investigator.\n11. Investigational drug use within 14 days (or 5 half-lives, whichever is longer) of the first dose of study treatment.\n12. Dexamethasone use \\> 4mg\u002Fday (or equivalent)",{"count":201,"type":21},[24],"This is a multicenter, phase II trial of relatlimab (rela), nivolumab (nivo), and ipilimumab (ipi) in patients with asymptomatic and symptomatic melanoma brain metastases.",[419,29],[571,572,573],"Relatlimab","Nivolumab","Ipilimumab","2026-05-15",{"date":510,"type":34},{"date":577,"type":34},"2025-08-06",{"date":579,"type":21},"2030-02",{"name":581,"class":41},"Stanford University",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":22,"phases":592,"briefSummary":593,"conditions":594,"keywords":595,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":71},"100608136","iomri-in-the-surgery-of-brain-metastases-100608136","NCT07197632","ioMRI in the Surgery of Brain Metastases.","Evaluation of the Efficacy and Safety of Intraoperative MRI in the Surgery of Brain Metastases.","MET-MRI","Inclusion Criteria:\n\n* Patients for whom surgical resection of brain metastasis is indicated\n\nExclusion Criteria:\n\n* age \\\u003C 18\n* 3T MRI contraindications",{"count":591,"type":21},154,[129],"The study aims to improve the surgical treatment of brain metastases through the use of advanced imaging techniques. The investigators are examining how intraoperative MRI (iMRI) can aid surgeons in precisely locating and removing tumors, with the potential to enhance surgical outcomes and reduce the need for additional procedures. While iMRI offers the promise of better tumor visualization during surgery, it is also associated with longer surgical times and may carry the risk of increased complications. This study seeks to carefully evaluate these aspects to determine the overall benefits and challenges of iMRI in brain metastasis surgeries. The ultimate aim is to enhance treatment effectiveness and improve recovery and health outcomes for participants dealing with brain metastases.",[29],[596,597,598],"ioMRI","Brain metastases","Neurosurgical resection","2026-05-03",{"date":601,"type":34},"2026-05-05",{"date":603,"type":34},"2025-01-17",{"date":605,"type":21},"2030-01-01",{"name":607,"class":41},"Technical University of Munich",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":616,"enrollmentInfo":617,"targetDuration":4,"studyType":22,"phases":619,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":253,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":71},"100636713","phase-1-il-8-receptor-modified-patient-derived-activated-cd70-car-t-cell-therapy-in-adults-with-brain-metastases-100636713","NCT07569263","IL-8 Receptor Modified Patient-Derived Activated CD70 CAR T Cell Therapy in Adults With Brain Metastases","A Phase I Study to Assess Safety and Feasibility of IL-8 Receptor Modified Patient-Derived Activated CD70 CAR T Cell Therapy in Adults With Brain Metastases From Primary Cancers (IMPACT-MET)","IMPACT MET","Inclusion Criteria:\n\n* Histological confirmation of primary cancers\n* Histologic confirmation of CD70 on primary tumor, lymph node, or BM biopsy\n* At least one recurrent or progressive metastatic lesion or new metastatic lesion(s).\n* KPS ≥ 70.\n* 18 years or older.\n* Adequate bone marrow and organ function as defined below:\n\n  * CBC with differential with adequate bone marrow function as defined below:\n  * Absolute neutrophil count (ANC) ≥ 10000 cells\u002Fmm3.\n  * Platelet count ≥ 75,000 cells\u002Fmm3.\n  * Hemoglobin ≥ 9 g\u002Fdl. (use of transfusion or other intervention to achieve Hgb ≥ 9 g\u002Fdl is acceptable.)\n* Adequate renal function as defined below:\n\n  * BUN ≤ 25 mg\u002Fdl\n  * Creatinine ≤ 1.7 mg\u002Fdl\n* Adequate hepatic function as defined below:\n\n  * Bilirubin ≤ 2.0 mg\u002Fdl\n  * ALT ≤ 5 times institutional upper limits of normal for age\n  * AST ≤ 5 times institutional upper limits of normal for age\n* A diagnostic contrast-enhanced brain MRI must be performed within 28 days prior to study enrollment.\n* For females of childbearing potential, a negative serum pregnancy test at enrollment.\n* Women of childbearing potential (WOCBP) must be willing to use an acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.\n* Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of the study drug.\n* Ability of the patient to understand and willingness to sign an IRB approved written informed consent document.\n* Steroid dose equivalent to dexamethasone dose of ≤ 6mg daily at the time of enrollment.\n* Patients treated on any other investigational therapy must discontinue that treatment prior to study entry.\n\nExclusion Criteria:\n\n• Known immunosuppressive disease or human immunodeficiency virus (HIV) infection.\n\nRationale: The need to exclude patients with an immunosuppressive disease or human immunodeficiency virus infection is necessary because the management of potential toxicities from the study drug may involve treatment that is significantly immunosuppressive.\n\n* Participant has ongoing toxicity ≥ grade 2 per the CTCAE version 5.0 considered clinically significant and in the opinion of the investigator, attributable to prior antineoplastic therapies.\n* Participant has received any chemotherapy or other immunotherapy within 14 days prior to the first dose of study intervention.\n* Severe, active co-morbidity, defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization.\n  * Transmural myocardial infarction within the last 6 months.\n  * Acute bacterial or fungal infection requiring intravenous antibiotics.\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization.\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects.\n  * Patients with an autoimmune disease requiring medical management with immunosuppressants.\n  * Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.\n* Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant.","80 Years",{"count":618,"type":21},12,[54],"This is a Phase I Study evaluating the safety and feasibility of IL-8 receptor-modified patient-derived activated CD70 CAR T cells in adult patients with brain metastases from primary cancer, with either newly diagnosed lesions or recurrent or progressive disease after prior therapy.",[29],[623,624],"Immunotherapy","CAR T cells","2026-04-29",{"date":627,"type":34},"2026-05-06",{"date":629,"type":21},"2026-07",{"date":631,"type":21},"2044-12",{"name":633,"class":41},"University of Florida",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":641,"sex":17,"minAge":18,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":22,"phases":644,"briefSummary":645,"conditions":646,"keywords":649,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":652,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":192},"100523850","development-of-mrf-for-characterization-of-brain-tumors-after-radiotherapy-100523850","NCT06101069","Development of MRF for Characterization of Brain Tumors After Radiotherapy","Development of Magnetic Resonance Fingerprinting for Characterization of Brain Tumors After Radiotherapy","Inclusion Criteria for Healthy Participants:\n\n* Ages 18 - 60\n* No history of cerebrovascular disease\n* No cognitive impairments\n* Able to provide informed consent\n\nInclusion Criteria for Participants with Brain Tumors:\n\n* Biopsy-proven cases of developed recurrent tumor or radiation necrosis, OR\n* a. PET identified with developed recurrent tumor or radiation necrosis. OR\n* b. Highly suspicious case with developed recurrent tumor or radiation necrosis confirmed by tumor board, attending physician or surgeon.\n* ECOG performance status 0-2.\n* Life expectancy \\> 6 months.\n* Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nInclusion Criteria for Participants with Brain Metastases or Primary Gliomas:\n\n* Radiology identified with developed primary gliomas tumor or brain metastases, OR\n* a. PET identified with developed gliomas tumor or brain metastases, OR\n* b. Highly suspicious case with developed gliomas tumor or brain metastases confirmed by tumor board\n* Participants must not have received prior radiation or surgical treatment for brain metastases or primary glioma.\n* Age: 18 years and over\n* ECOG performance status 0-2\n* Life expectancy \\> 6 months.\n* Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nInclusion Criteria for Participants with Meningiomas:\n\n* Radiology identified with resectable meningioma\n* Participants have no prior radiation or surgical treatment for brain lesions\n* Age: 18 years or older\n* ECOG performance status 0-2\n* Life expectancy \\> 6 months.\n* Participants with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nExclusion Criteria:\n\n* Pregnant women OR lactating women\n* Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips.\n* Participants who cannot go into the MRI scanner due to metal implants and other medical conditions.\n* The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator.\n* Participants with contraindications for MRI due to embedded foreign metallic objects such as bullets, shrapnel, metalwork fragments, or other metallic material.\n* Known history of severe claustrophobia.\n* Participants unable to lay still in the scanner for 30 minutes at a time.",true,"60 Years",{"count":102,"type":21},[129],"The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, individuals with previously untreated tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study.\n\nThe primary objectives of this study are:\n\n* To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage.\n* To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis.\n* To investigate the effect of radiation dose on the development of radiation necrosis and tumor recurrence.",[428,647,29,648],"Brain Necrosis","Glioma",[650,651],"Magnetic Resonance Fingerprinting","Radiation necrosis",{"date":601,"type":34},{"date":654,"type":34},"2024-10-14",{"date":656,"type":21},"2026-09",{"name":118,"class":41},{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":665,"minAge":18,"maxAge":666,"enrollmentInfo":667,"targetDuration":4,"studyType":22,"phases":668,"briefSummary":669,"conditions":670,"keywords":672,"overallStatus":253,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":71},"100634443","phase-2-brain-radiotherapy-combined-with-dalpiciclib-and-endocrine-therapy-in-hr-positiveher2-negative-advanced-breast-cancer-with-brain-metastases-100634443","NCT07539753","Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive\u002FHER2-Negative Advanced Breast Cancer With Brain Metastases","A Single-Arm, Phase II Study of Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive\u002FHER2-Negative Advanced Breast Cancer Patients With Brain Metastases","Inclusion Criteria:\n\n* 1.Female patients aged 18 to 75 years, who are postmenopausal or premenopausal\u002Fperimenopausal, and meet at least one of the following conditions:\n\n  1. prior bilateral oophorectomy; or age ≥60 years; or\n  2. age \\\u003C60 years and postmenopausal status defined as at least 12 consecutive months of spontaneous amenorrhea without other pathological or physiological causes, with estradiol (E2) and follicle-stimulating hormone (FSH) levels within the postmenopausal range; or\n  3. premenopausal or perimenopausal women are also eligible if they are willing to receive treatment with an LHRH agonist during the study.\n* 2.Histologically or cytologically confirmed HR-positive, HER2-negative breast cancer in female patients, with evidence of locally recurrent or metastatic disease that is not amenable to curative surgery or radiotherapy, and with no clinical indication for chemotherapy.\n* HR-positive is defined as ER-positive and\u002For PR-positive, with ≥1% of tumor cells showing positive staining, as confirmed by the investigator at the study site.\n* HER2-negative is defined as IHC 0 or 1+, or ISH-negative, defined as a HER2\u002FCEP17 ratio \\\u003C2.0 or an average HER2 copy number \\\u003C4.0, as confirmed by the investigator at the study site.\n* 3.Presence of brain metastases confirmed by MRI, with at least one measurable intracranial lesion ≥1 cm according to RECIST version 1.1. Measurable extracranial disease is not required.\n* 4.ECOG performance status 0-2, and an estimated life expectancy of at least 12 weeks at the time of enrollment.\n* 5.If the patient is receiving corticosteroids, the corticosteroid dose must be stable or decreasing for at least 5 days before the brain gadolinium-enhanced MRI (Gd-MRI). This MRI must be performed within 28 days before enrollment. Patients who require an increased steroid dose before treatment, or who are receiving an unstable steroid dose, are not eligible.\n* 6.Screening laboratory values must meet the following criteria( and should be obtained within 14 days prior to registration)::\n\n  1. absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³ (1.5 × 10\\^9\u002FL), without growth factor support within 14 days;\n  2. platelet count (PLT) ≥ 100,000\u002Fmm³ (100 × 10\\^9\u002FL), without corrective treatment within 7 days;\n  3. hemoglobin (Hb) ≥ 9 g\u002FdL (90 g\u002FL), without corrective treatment within 7 days;\n  4. serum creatinine (Scr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance ≥ 60 mL\u002Fmin;\n  5. total bilirubin ≤ 1.5 × ULN;\n  6. aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 2.5 × ULN, or ≤ 5 × ULN for patients with liver metastases.\n* 7.Prior stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT) is permitted, provided that the currently active measurable disease has not been previously treated with radiotherapy.\n* 8.Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and must agree to use a medically acceptable highly effective method of contraception during the study and for 1 year after the last dose of study treatment.\n* 9.Ability and willingness to signed the informed consent form prior to patient entry.\n\nExclusion Criteria:\n\n* 1.Prior pathological diagnosis of HER2-positive breast cancer.\n* 2.Prior disease progression on dalpiciclib in the metastatic setting.\n* 3.Primary endocrine resistance, defined as either:\n\n  1. disease recurrence or progression within 2 years of starting adjuvant endocrine therapy; or\n  2. disease progression within 6 months of first-line endocrine therapy for advanced or metastatic disease.\n* 4.Patients considered not suitable for endocrine therapy in the judgment of the investigator, including patients with symptomatic visceral disease, disseminated visceral involvement, or a risk of life-threatening complications in the short term, such as uncontrolled massive effusions (pleural, pericardial, or peritoneal), lymphangitic carcinomatosis of the lung, or \\>50% liver involvement.\n* 5.Presence of leptomeningeal metastases.\n* 6.Prior whole-brain radiotherapy (WBRT) .\n* 7.Any severe neurologic symptoms caused by central nervous system metastases.\n* 8.Pregnant or breastfeeding women.\n* 9.Any serious uncontrolled clinical disease or infection that, in the investigator's judgment, cannot be adequately controlled with appropriate treatment or may impair the patient's ability to tolerate study treatment, including but not limited to:\n\n  1. serious cardiovascular events such as syncope of cardiovascular origin, pathologic ventricular arrhythmias (including but not limited to ventricular tachycardia or ventricular fibrillation), or cardiac arrest;\n  2. end-stage renal disease;\n  3. severe liver disease;\n  4. active systemic bacterial infection.\n* 10.History of immunodeficiency, including HIV infection, active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, other acquired or congenital immunodeficiency disorders, or prior organ transplantation.\n* 11.History of malignancy other than breast cancer.\n* 12.Inability to swallow oral medication, or presence of chronic diarrhea, intestinal obstruction, or other conditions that may interfere with the administration or absorption of study drugs.\n* 13.History of allergy or hypersensitivity to any study drug or any of its components.","FEMALE","75 Years",{"count":20,"type":21},[24],"This is a prospective, open-label, exploratory clinical trial designed to evaluate the efficacy and safety of brain radiotherapy combined with dalpiciclib and endocrine therapy in HR-positive\u002FHER2-negative advanced breast cancer patients with brain metastases. A total of 46 patients are planned to be enrolled.\n\nParticipants will receive dalpiciclib plus endocrine therapy and brain radiotherapy, including fractionated stereotactic radiotherapy (FSRT) or whole-brain radiotherapy (WBRT), according to the clinical characteristics of brain metastatic lesions. Radiotherapy may start within 30 days before or after initiation of drug treatment. Dalpiciclib and endocrine therapy may be given concurrently during radiotherapy and will be continued after radiotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator decision. Participants will visit the clinic once every 3 months for checkups and tests. Tumor response will be assessed according to RECIST version 1.1, and safety will be evaluated throughout the study.",[252,29,671],"HR+\u002FHER2- Breast Cancer",[671,458,673,674],"brain radiotherapy","dalpiciclib","2026-04-24",{"date":677,"type":34},"2026-04-30",{"date":679,"type":21},"2026-06-01",{"date":681,"type":21},"2029-08-01",{"name":683,"class":41},"Nanfang Hospital, Southern Medical University"]