Dosimetry, Safety and Diagnostic Testing of 68Ga-FC516 in Healthy Adults and Men with Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The first affiliated hospital of Jinan University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Tingjin Wang
• Email: wangtingjin@find-cure.com
• Phone: 18664044814

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.