[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HTA Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100651777","phase-3-a-clinical-study-evaluating-the-diagnostic-performance-and-safety-of-pet-for-the-deposition-of-a-plaques-in-the-brain-of-participants-with-normal-cognitive-function-mci-and-ad-using-18ffluorbetazine-injection-100651777",false,"NCT07764679","A Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection","A Multicenter Phase III Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection","Inclusion Criteria:\n\n1 1. Men or women aged ≥ 40 years (including the threshold age). 2. Men or women with fertility must use effective contraceptive measures during the study period. Effective contraceptive measures include sterilization, intrauterine hormone devices, condoms, birth control pills, abstinence, or vasectomy.\n\n3\\. Meet the diagnostic criteria for normal cognitive function, Mild Cognitive Impairment (MCI), or Alzheimer's disease (AD).\n\n4\\. Participants voluntarily join the study, can cooperate with the experimental observations, and sign a written informed consent form. For participants with AD dementia, the informed consent form must be signed together with their legal guardian. If the participant is unable to sign the informed consent form due to limited cognitive ability or other reasons, the participant's signature space may be left blank, with the reason documented. The guardian should sign in the designated space for explanation.\n\nExclusion Criteria:\n\n1. Known allergy to \\[18F\\]Fluorbetazine injection or its excipients.\n2. Presence of previously implanted metal devices that are incompatible with MRI examinations, including pacemakers, defibrillators, insulin pumps, cochlear implants, intraocular metal implants, nerve stimulators, or CNS aneurysm clips; or suffering from claustrophobia or intolerance to imaging procedures for other reasons.\n3. Cognitive impairment caused by reasons other than Alzheimer's disease (AD).\n4. Cranial MRI scan shows one or more of the following results:\n\n   * More than 2 infarctions with a diameter greater than 2 cm in any part of the brain;\n   * Infarctions of any diameter in key areas such as the thalamus, hippocampus, entorhinal cortex, hippocampal gyrus, gyrus, cortex, or other subcortical gray matter nuclei;\n   * Fazekas Scale grading of white matter lesions \\> 2;\n   * Presence of brain tumors, intracranial infections, or cerebral hemorrhage, and deemed unsuitable for participation in this study by the researchers.\n5. Current clinically significant psychiatric illnesses, such as severe depression or schizophrenia, based on medical history, and the researchers have assessed that the imaging process cannot be completed. Researchers should carefully consider whether participants with dementia and behavioral disorders who may require psychiatric medication can complete the imaging process.\n6. Received radiopharmaceutical imaging or treatment within at least 5 half-lives prior to screening.\n7. Suffering from other serious and\u002For poorly controlled and\u002For unstable diseases, and deemed unsuitable for participation in this study by the researcher.\n8. Positive test results for human immunodeficiency virus (HIV) antibodies or Treponema pallidum antibodies.\n9. History of alcohol or drug abuse.\n10. Pregnant or lactating women with positive pregnancy test results during the screening period (including premenopausal women who have not undergone surgical sterilization and women within one year after menopause).\n11. Participated in any clinical trials within 4 weeks prior to enrollment and used investigational drugs; or those who plan to participate in any clinical trials during the study period.\n12. Other situations deemed unsuitable for participating in this clinical trial by the researchers.\n\nParticipants with Normal Cognitive Function\n\n1\\. Any evidence suggesting the possibility of AD from previous MRI, CT, or other biomarker studies.\n\nMCI and AD Dementia Participants\n\n1. Received anti-Aβ targeted therapy drugs, such as lecanemab monoclonal antibody, or treated or prophylactic anti-Aβ vaccines.\n2. Suffering from neurodegenerative diseases other than AD, including but not limited to Parkinson's disease, Pick's disease, frontotemporal degeneration (FTLD), Huntington's disease, Down syndrome, Creutzfeldt-Jakob disease, normal pressure hydrocephalus, or progressive supranuclear palsy (PSP).\n3. Previously or currently diagnosed with dementia other than AD, including but not limited to Parkinson's disease dementia, Lewy body dementia, frontotemporal dementia, vascular dementia, mixed dementia, etc.",true,"ALL","40 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using \\[18F\\]Fluorbetazine injection.",[27,28],"Mild Cognitive Impairment (MCI)","Alzheimer's Disease (AD)","RECRUITING","2026-08-13",{"date":32,"type":33},"2026-08-14","ACTUAL",{"date":35,"type":33},"2025-06-20",{"date":37,"type":21},"2028-12-31",{"name":39,"class":40},"HTA Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100597371","phase-3-a-phase-iii-clinical-study-to-compare-the-safety-and-efficacy-of-177lu-dotatate-injection-and-long-acting-oxytrexine-in-adult-patients-with-nets-100597371","NCT07057622","A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETs","Compare the Safety and Efficacy of 177Lu-DOTATATE and Octreotide LAR in Unresectable or Metastatic, Progressive, Well-differentiated(G1 and G2) and SSTR-positive Adult GEP-NEN","Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent document;\n2. Age ≥18 years ;\n3. Low-and medium-grade ( G1 or G2) unresectable locally advanced or metastaticgastrointestinalneuroendocrine tumors(GEP-NETs)confirmed by histopatholog in the central laboratory,and those who had previously progressed after standard-dose somatostatin analogue(SSA)treatment;\n4. Somatostatin receptor positive patients must be defined as all target lesions at baseline confirmed by PET\u002F CT examination of gallium \\[68Ga\\] dobutamine injection as somatostatin receptor positive(IRC confirmed);\n5. There is at least one measurable lesion at baseline;\n6. BaselineECOG score 0 or 1;\n7. Adeguate organ and bone marrow function as defined below:\n\n   a) bone marrow:Neutrophil count (ANC)≥1.5×109\u002FL, platelet count ≥75×109\u002FL,hemoglobin ≥80g\u002FL,no blood transfusion or growth factor treatment within 14 days before randomization.(colony stimulating factor (CSF), colony stimulating factor (CSF),Erythropoietin(EPO),etc.); b) Liver function:aspartate aminotransferase(AST)and alanine aminotransferase(ALT)≤2.5 ULN; total bilirubin( TBIL ) ≤1.5 × ULN; c ) Renal function : serum creatinine ≤150μmol\u002F L or 1.7mg \u002F dL, or creatinine clearance rate (CLcr)≥50mL\u002Fmin calculated by Cockroft Gault method; d) Baseline left ventricular ejection fraction (LVEF)≥50 % measured by multi-gate circuit controlled acquisition(MUGA) or echocardiography(ECHO); e ) Coagulation function: international normalized ratio(INR)≤1.5 ×ULN,activated partial thromboplastin time(APTT ) ≤1.5 × ULN ; f) Serum albumin \\> 3.0g\u002F dL.\n8. Subjects with childbearing potential voluntarily use effective contraceptive methods,such as condoms, oral or injectable contraceptives, intrauterine devices, etc, during treatment and within 4 months (men) or 7months(women)after the last use of the investigational drug.\n\nExclusion Criteria:\n\n1. Human immunodeficiency virus (HIV) antibody positive;\n2. Hepatitis B virus (HBV) surface antigen (HBsAg) is positive and HBV-DNA is positive (≥the upper limit of detection), or hepatitis C virus (HCV) antibody (HCV-Ab) is positive and HCV-RNA is positive (≥the upper limit of detection));\n3. Pregnant or lactating women;\n4. Received peptide receptor radionuclide therapy (PRRT) before randomization;\n5. Received Octreotide LAR treatment with a dose intensity \\>30 mg\u002F3-4 weeks (increased dose or frequency) within 12 weeks before randomization;\n6. Subjects who are receiving short-acting octreotide treatment cannot stop short-acting octreotide within 24 hours before and 24 hours after administration of 177Lu-DOTATATE or subjects who are receiving Octreotide LAR treatment cannot stop Octreotide LAR within 4 weeks before administration of 177Lu-DOTATATE;\n7. Have received systemic anti-tumor treatments such as targeted therapy, immunotherapy,anti-tumor Chinese medicine treatment, chemotherapy,etc.within 4 weeks before randomization;\n8. Participated in other drug clinical trials and received corresponding experimental drugs within 4 weeks before randomization, except for the PET\u002FCT study of the diagnostic drug68Ga-DOTATATE injection initiated by the sponsor of this trial;\n9. Received the following treatments within 12 weeks before randomization,including but not limited to surgery (except biopsy),radical radiotherapy,hepatic artery interventional embolization,cryoablation or radiofrequency ablation of liver metastases;\n10. Received palliative radiotherapy for bone metastases within 2 weeks before randomization;\n11. The toxicity of previous anti-tumor treatment has not recovered to s grade 1 level (except for hair loss and neurotoxicity);\n12. Known brain metastasis (except those who have received treatment and been stable for at least 24 weeks before randomization);\n13. Severe cardiac insufficiency,including congestive heart failure 2 grade 2 (New York Heart Association classification), myocardial infarction, stroke or transient ischemic attack (TIA) history within 6 months before enrollment; 14.History of ventricular tachycardia or torsade de pointes.Any clinically important abnormality in resting ECG rhythm, conduction,or morphology, such as QTcF \\>450 msec in men or QTcF\\>470 msec in women, the presence of complete left bundle branch block or third-degree atrioventricular block;\n\n15\\. Pulmonary embolism or deep vein thrombosis occurred within 3months before randomization; 16.Uncontrolled hypertension(e.g.systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg)and uncontrolled diabetes ( baseline fasting blood glucose \\>8.9 mmol\u002F L or glycosylated hemoglobin(HbA1C)\\>6.5%); 17.There were uncontrolled active bacterial, viral,fungal,rickettsial or parasitic infections requiring intravenous anti-infective therapy within the first 2 weeks of randomization; 18.There were concurrent malignant tumors within the first 5 years of enrollment (except for fully treated cervical carcinoma in situ,localized skin squamous cell carcinoma,basal cell carcinoma, prostate cancer without anti-tumor treatment,thyroid cancer,breast ductal carcinoma in situ, and urothelial carcinoma below T1); 19. Known allergies to 68Ga-DOTATATE injection or 177Lu-DOTATATE injection or Octreotide LAR components and theirexcipients; 20. Any other disease or mental state that is not under control and may affect the completion of the study (including poor compliance) or is not suitable for the use of experimental drugs; 21.According to the patient \\'s disease characteristics,the researchers believe that other treatment options (such as chemotherapy,targeted therapy) are more suitable for patients than the treatment provided in the study,that is,the experimental drugs are not the best therapeutic drugs in clinical practice.","18 Years",{"count":51,"type":21},184,[24],"The study is to evaluate the sstr antagonists, 68Ga-DOTATATE and 177Lu-DOTATATE,as a pair of diagnostic\u002Ftherapeuticradiopharmaceuticals(theranostics)in patients with NETS",[55],"NETS Ga68 Lu177","2025-07-08",{"date":58,"type":33},"2025-07-10",{"date":60,"type":33},"2023-12-12",{"date":62,"type":21},"2027-02-24",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":71,"minAge":49,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":41},"100574038","phase-3-study-of-18f-florastamin-petct-imaging-in-patients-with-suspected-recurrence-of-prostate-cancer-100574038","NCT06754085","Study of 18F-Florastamin PET\u002FCT Imaging in Patients With Suspected Recurrence of Prostate Cancer","A Phase III, Prospective, Open-Label, Single-Arm, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET\u002FCT Imaging in Patients With Suspected Recurrence of Prostate Cancer","Inclusion Criteria:\n\n1. Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).\n2. Male ≥ 18 years of age.\n3. Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy.\n4. Suspected recurrence or distant metastasis of prostate cancer based on any of the following conditions:\n\n   1. At least 6 weeks after radical prostatectomy (RP): PSA ≥0.2 ng\u002FmL followed by a subsequent confirmatory PSA value ≥0.2 ng\u002FmL.; or\n   2. Post-radiation therapy, after radical radiotherapy (or cryoablation therapy): Increase in PSA level that is elevated by ≥ 2 ng\u002FmL above the nadir .\n5. Subjects who are willing to undergo biopsy, salvage surgery, or radiation therapy based on the researcher's clinical judgment;\n6. ECOG score 0 or 2.\n7. Subjects who meet the following conditions in hematology, renal function, and liver function:\n\n   Platelet count\\>50 \\* 10\\^9\u002FL Urea\u002Furea nitrogen and creatinine\\\u003C1.5 times upper limits of normal AST and ALT\\\u003C2.5 times upper limits of normal.\n8. Expected survival time ≥ 6 months.\n9. Subjects and their partners must use effective contraceptive measurements and avoid sperm donation from the date of signing ICF to 3 months after administration.\n\nExclusion Criteria:\n\n1. Subjects who have participated in other interventional clinical trials before signing ICF and were within the 5 half-lives of the investigational drug, or who are currently participating in other interventional clinical trials or have participated in clinical trials of radioactive drugs before signing ICF and have been discontinued for less than 3 months until the signing date of ICF.\n2. Intravenous injection of iodinated contrast medium within 24 hours, or any high-density oral contrast medium (Such as barium sulfate. Oral water contrast is acceptable, such as compound meglumine diatrizoate oral liquid) within 5 days, prior to study drug administration.\n3. Subjects administered any high energy (\\>300 KeV) gamma-emitting radioisotope within five physical half-lives prior to study drug administration.\n4. If previously taking ADT, it should have been discontinued at least 16 weeks prior to study drug administration.\n5. The investigator determines that there are any medical diseases or other conditions that affect the safety or compliance of the subjects.","MALE",{"count":73,"type":21},131,[24],"In this study, 18F-Florastamin PET\u002FCT will be performed in patients with suspected recurrence of prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET\u002FCT imaging.",[77],"Prostate Cancer","2024-12-23",{"date":80,"type":33},"2024-12-31",{"date":82,"type":33},"2024-12-19",{"date":84,"type":21},"2026-05-01",{"name":39,"class":40},""]