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Recruiting Early Phase 1 NCT07468708

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

Very early trial – mainly for safety
Conditions: Healthy Adult Prostate Cancer

Sponsor: FindCure Biosciences (ZhongShan) Co., Ltd.

trial.available_in: БГ
Overview
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 PSMA-targeting tracer or ⁶⁸Ga-labeled ACP3-targeting tracer imaging to evaluate the dosimetric characteristics and diagnostic efficacy of ⁶⁸Ga-FC516.
Who can participate
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.
Interventions
⁶⁸Ga-FC516
DRUG
⁶⁸Ga-FC516 and ⁶⁸Ga-labeled PSMA-targeting tracer
DRUG
⁶⁸Ga-FC516 and ⁶⁸Ga-labeled ACP3-targeting tracer
DRUG
Locations 1
China (1)
The first affiliated hospital of Jinan University
Guangzhou , Guangdong
Technical details
Status
Recruiting
Phase
Early Phase 1
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Healthy volunteers
No
Start date
09.03.2026
Completion date
01.08.2026
Registry ID
NCT07468708
Source
clinicaltrials.gov
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