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Clinical Trials in China / NCT07468708
Recruiting Early Phase 1

The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer

NCT07468708 · tracked via the Priya Life Science China tracker
Sponsor
FindCure Biosciences (ZhongShan) Co., Ltd
Phase
Early Phase 1
Started
2026-03-09
Last updated
2026-09-09

Condition(s) studied

Healthy AdultProstate Cancer

Investigational drug(s) / intervention(s)

⁶⁸Ga-FC516⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer

⁶⁸Ga-FC516: Healthy subjects will receive ⁶⁸Ga-FC516 injection followed by PET/CT scans at multiple timepoints post-administration.

⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer: Patients with prostate cancer will undergo both ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT scans with a minimum interval of 24 hours and a maximum of 14 days between the two.

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Frequency of adverse events (AEs) and SAEs — Approximately 6 months
  • Standard uptake value (SUV) of tumors — Approximately 6 months
    Compare the SUV of tumor between 68Ga-FC516 PET/CT and 68Ga-labeled prostate cancer-targeting tracer PET/CT
  • Human dosimetry — Approximately six months
    Radiation dose to individual organs and the equivalent dose for the whole body of each subject.

Trial sites (1)

FacilityCityRegionStatus
The first affiliated hospital of Jinan University Guangzhou Guangdong Recruiting

More FindCure Biosciences (ZhongShan) Co., Ltd. trials in China

The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors Recruiting
The Safety, Dosimetry and Efficacy of 177Lu-FC516 in Patients With Prostate Cancer Recruiting
A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors Recruiting

Other trials for the same condition

A Study of SHR-4394 Injection in Subjects With Prostate Cancer Recruiting
AI Multimodal Model for Predicting CRPC Progression Risk Active, not recruiting
Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy Active, not recruiting
Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis Recruiting
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07468708 on ClinicalTrials.gov ↗ ← All trials in China