The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
Recruiting · NCT07468708 · Interventional (participants receive a specific treatment) · Lead sponsor: FindCure Biosciences (ZhongShan) Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
⁶⁸Ga-FC516⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- The first affiliated hospital of Jinan University - Guangzhou, Guangdong, China