[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Primo Biotechnology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100053302","phase-3-clinical-benefit-of-18f-fet-in-glioma-100053302",false,"NCT07698457","Clinical Benefit of 18F-FET in Glioma.","The Clinical Benefit of 18F-Fluoroethyl-l-tyrosine(FET) PET\u002FCT in Glioma Patients.","* Inclusion criteria： For health volunteers\n\n  1. Participants must be ≥ 20 years old.\n  2. Participants are alert and oriented, and able to independently sign ICF. For glioma patients\n\n  \u003C!-- -->\n\n  1. Participants must be ≥ 20 years old.\n  2. Participants with suspected primary gliomas scheduled for surgery.\n  3. Participants are alert and oriented, and able to independently sign ICF.\n* Exclusion criteria：\n\n  1. Liver dysfunction within the past 6 months (e.g., AST\u002FALT ratio \\> 2, total bilirubin \\> 1.5 mg\u002FdL).\n  2. Chronic kidney disease stage 4 (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2) within the last 6 months.\n  3. Acute kidney injury within the past 6 months.\n  4. Allergic to any radiopharmaceuticals or contrast agents.\n  5. Restlessness or inability to lie in a cast for 30 to 60 minutes.\n  6. Women who are pregnant, lactating, or planning pregnancy during the study period or before screening.\n  7. PI deemed the participant unsuitable.\n  8. The patient is not able to understand the treatment options.",true,"ALL","20 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This Phase II clinical trial, sponsored by \\*\\*Primo Biotechnology Co., Ltd.\\*\\*, evaluates the clinical benefit of \\*\\*$\\^{18}$F-FET PET\u002FCT\\*\\* in diagnosing glioma. The study aims to compare the diagnostic performance of $\\^{18}$F-FET PET imaging against traditional brain MRI, using surgical histopathology as the gold standard for verification.\n\n\\*\\*Study Design and Participants\\*\\* This is a single-center, open-label, non-randomized trial conducted in Taiwan. The study will enroll a total of \\*\\*36 participants\\*\\*, consisting of 6 healthy volunteers (to assess biodistribution and dosimetry) and 30 patients with suspected primary gliomas scheduled for surgery.\n\n\\*\\*Methodology\\*\\* The test drug, $\\^{18}$F-FET, is a radiopharmaceutical that targets large neutral amino acid transporters (LAT). It is administered via intravenous injection at a dosage of 3MBq\u002Fkgw.\n\n* \\*\\*Volunteers\\*\\* undergo PET\u002FCT scans immediately and every 20 minutes for 90 minutes.\n* \\*\\*Patients\\*\\* receive a static PET scan 40-50 minutes post-injection.\n\n\\*\\*Endpoints and Safety\\*\\*\n\n* \\*\\*Primary Endpoint:\\*\\* Diagnostic sensitivity compared to MRI.\n* \\*\\*Secondary Endpoints:\\*\\* Specificity, PPV, NPV, tumor-to-background ratios (TBR), and safety (adverse events\u002Fvital signs).\n* \\*\\*Radiation Safety:\\*\\* The total estimated radiation exposure is \\*\\*7.63 mSv\\*\\*, which is well below the international safety threshold of 100 mSv.\n\n\\*\\*Conclusion\\*\\* The trial seeks to establish $\\^{18}$F-FET PET\u002FCT as a safe and effective diagnostic tool for the pre-surgical assessment of gliomas, potentially providing higher sensitivity and more accurate lesion detection than conventional MRI in Asian cancer patients.",[27,28],"Glioma","18F-Fluoroethyl-l-tyrosine",[30,31,32],"18F-FET","MRI","Diagnostic accuracy","NOT_YET_RECRUITING","2026-07-07",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":21},"2026-10-01",{"date":41,"type":21},"2028-01-31",{"name":43,"class":44},"Primo Biotechnology Co., Ltd","INDUSTRY",4,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100587958","phase-1-detecting-colorectal-cancer-with-liver-metastatic-lesions-using-novel-precise-imaging-tools-100587958","NCT06935149","Detecting Colorectal Cancer With Liver Metastatic Lesions Using Novel Precise Imaging Tools","Detecting Liver Metastatic Lesions in Patients of Colorectal Cancer With Novel Precise Imaging Tools","PSMA","Main inclusion criteria:\n\n1. The participants can voluntarily sign informed consent forms\n2. The participants are male\u002Ffemale over 20 years old.\n3. The participant is currently undergoing cancer staging based on the previous pathological diagnosis of colorectal cancer\n4. The participants are confirmed liver metastasis by CT, abdominal ultrasound, MRI, and FDG PET\u002FCT within 30 days before receiving PSMA-PET\u002FCT.\n5. WHO performance status ≦ 2 points\n6. The participants can lie on table for two hours during PSMA-PET\u002FCT scanning.\n\nMain exclusion criteria: To improve the accurate interpretation of PMSA-PET imaging and reduce the occurrence of related-drug adverse events, the participants will be excluded by following below criteria.\n\n1. The colorectal cancer participants was diagnosed other organs metastases with multiple organ metastases not only the liver.\n2. The colorectal cancer participants have undergone any treate after diagnosis of liver metastasis.\n3. The participants have suffered from liver dysfunction such as AST\u002FALT ratio \\>2、total bilirubin \\>1.5 mg\u002FdL within 6 months.\n4. The participants suffered stage IV chronic kidney disease (eGFR\\\u003C30 mL\u002Fmin\u002F1.73 m2) within 6 months.\n5. The participants suffered acute kidney injury within 6 months.\n6. The participants suffered trauma or fracture.\n7. The participants are allergic to any radiopharmaceutical or imaging agent.\n8. The participants are history of claustrophobia or are inability to remain quiet during the examination.","100 Years",{"count":56,"type":21},5,[58],"PHASE1","This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis.",[61],"Liver Metastasis Colon Cancer",[63,52,64],"Liver metastasis","PET","2025-04-18",{"date":67,"type":37},"2025-04-24",{"date":69,"type":21},"2025-05-01",{"date":71,"type":21},"2025-12-31",{"name":43,"class":44},""]