Dosimetry, Safety and Diagnostic Testing of 68Ga-FC516 in Healthy Adults and Men with Prostate Cancer
Evaluation of Dosimetry, Safety, Biodistribution and Preliminary Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
This trial will test whether a new PET tracer called 68Ga-FC516 is safe and produces clear diagnostic images in healthy adults and men with prostate cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | FindCure Biosciences (ZhongShan) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07468708 on ClinicalTrials.gov |
What this trial studies
This early-phase interventional study enrolls two cohorts: healthy adult volunteers for dosimetry and men with histologically confirmed prostate cancer for diagnostic imaging. Participants receive 68Ga-FC516 and undergo serial PET/CT scans to measure biodistribution and organ radiation dose. In patients with prostate cancer, imaging with 68Ga-FC516 will be compared to a standard 68Ga-labeled prostate cancer-targeting tracer to compare diagnostic performance. Safety monitoring includes recording adverse events and routine clinical laboratory tests.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who are either healthy volunteers for dosimetry work or men with prostate cancer confirmed by histopathology who can undergo PET/CT imaging.
Not a fit: Patients with severe liver, kidney, or cardiac impairment, those unable to undergo PET/CT (for example due to severe obesity), or those with hypersensitivity to tracer components are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, 68Ga-FC516 could provide safer, more accurate PET imaging for detecting and staging prostate cancer.
How similar studies have performed: Other 68Ga-labeled tracers such as PSMA agents have shown strong diagnostic performance in prostate cancer, but 68Ga-FC516 is a novel tracer whose dosimetry and diagnostic utility remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- The first affiliated hospital of Jinan University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Tingjin Wang
- Email: wangtingjin@find-cure.com
- Phone: 18664044814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.