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
FindCure Biosciences (ZhongShan) Co., Ltd.
10 participants
Mar 9, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Voluntarily participate the clinical study; sign the informed consent form;
- Aged 18 years or older;
- Cohort A: Healthy subjects;
- Cohort B: Patients with prostate cancer confirmed by histopathological or cytological diagnosis;
Exclusion Criteria4
- Severe impairment of liver, kidney, or cardiac function;
- Severe obesity or other conditions that prevent or make PET/CT scanning impossible;
- Hypersensitivity to any active or inactive components of the study drug;
- Other subjects deemed unsuitable for enrollment by the investigators.
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Interventions
Healthy subjects will receive ⁶⁸Ga-FC516 injection followed by PET/CT scans at multiple timepoints post-administration.
Patients with prostate cancer will undergo both ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT scans with a minimum interval of 24 hours and a maximum of 14 days between the two.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07468708