[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628981":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":55,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":11,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"FindCure Biosciences (ZhongShan) Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"⁶⁸Ga-FC516 PET\u002FCT","EXPERIMENTAL",null,[13],"Drug: ⁶⁸Ga-FC516",{"label":15,"type":10,"description":11,"interventionNames":16},"⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET\u002FCT",[17],"Drug: ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","⁶⁸Ga-FC516","Healthy subjects will receive ⁶⁸Ga-FC516 injection followed by PET\u002FCT scans at multiple timepoints post-administration.",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer","Patients with prostate cancer will undergo both ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET\u002FCT scans with a minimum interval of 24 hours and a maximum of 14 days between the two.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Tingjin Wang","CONTACT","18664044814","wangtingjin@find-cure.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":11,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The first affiliated hospital of Jinan University","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":43,"coordinates":44},"Point",[45,46],113.25,23.11667,{"lat":46,"lon":45},[49,53],{"name":50,"role":31,"phone":51,"phoneExt":11,"email":52},"Lu Wang, Doctor","020-36868405","l_wang1009@foxmail.com",{"name":50,"role":54,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[58],{"name":59,"class":60},"First Affiliated Hospital of Jinan University","OTHER","100628981","early-phase-1-the-dosimetry-safety-and-diagnostic-efficacy-of-ga-fc516-in-healthy-subjects-and-patients-with-prostate-cancer-100628981",false,"NCT07468708","The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer","Evaluation of Dosimetry, Safety, Biodistribution and Preliminary Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer","Inclusion Criteria:\n\n1. Voluntarily participate the clinical study; sign the informed consent form;\n2. Aged 18 years or older;\n3. Cohort A: Healthy subjects;\n4. Cohort B: Patients with prostate cancer confirmed by histopathological or cytological diagnosis;\n\nExclusion Criteria:\n\n1. Severe impairment of liver, kidney, or cardiac function;\n2. Severe obesity or other conditions that prevent or make PET\u002FCT scanning impossible;\n3. Hypersensitivity to any active or inactive components of the study drug;\n4. Other subjects deemed unsuitable for enrollment by the investigators.",true,"MALE","18 Years",{"count":72,"type":73},10,"ESTIMATED","INTERVENTIONAL",[76],"EARLY_PHASE1","This goal of this study is to investigate the dosimetry, safety, biodistribution of ⁶⁸Ga-FC516. In this study, we will evaluate the safety, biodistribution and dosimetry of ⁶⁸Ga-FC516 in subjects and compared them with the results of ⁶⁸Ga-labeled prostate cancer-targeting tracer imaging to evaluate the dosimetric characteristics and diagnostic efficacy of ⁶⁸Ga-FC516.",[79,80],"Healthy Adult","Prostate Cancer","2026-04-24",{"date":83,"type":84},"2026-04-29","ACTUAL",{"date":86,"type":84},"2026-03-09",{"date":88,"type":73},"2026-08",{"name":5,"class":6},1]