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

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.

Inclusion Criteria:

1. Voluntarily participate the clinical study; sign the informed consent form;
2. Aged 18 years or older;
3. Cohort A: Healthy subjects;
4. Cohort B: Patients with prostate cancer confirmed by histopathological or cytological diagnosis;

Exclusion Criteria:

1. Severe impairment of liver, kidney, or cardiac function;
2. Severe obesity or other conditions that prevent or make PET/CT scanning impossible;
3. Hypersensitivity to any active or inactive components of the study drug;
4. Other subjects deemed unsuitable for enrollment by the investigators.