Tests a radioactive imaging tracer in healthy people and people with prostate cancer
Tests a radioactive tracer scan, ⁶⁸Ga-FC516, in healthy adults and men with prostate cancer.
Plain-language title generated from the registry record
Registry title: The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Early phase 1
Where in China
- The First Affiliated Hospital of Jinan UniversityGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- FindCure Biosciences (ZhongShan) Co., Ltd.
- Trial code
- NCT07468708
- Record updated
- 9 September 2026
- Original description
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.Read full original descriptionShow less
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: 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: 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.