About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ⁶⁸Ga-FC516
- ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer
Treatment groups
Sponsors and collaborators
FindCure Biosciences (ZhongShan) Co., Ltd.
Lead sponsor
First Affiliated Hospital of Jinan University
Collaborator