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The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
Sponsor: FindCure Biosciences (ZhongShan) Co., Ltd.
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 PSMA-targeting tracer or ⁶⁸Ga-labeled ACP3-targeting tracer imaging to evaluate the dosimetric characteristics and diagnostic efficacy of ⁶⁸Ga-FC516.
Official title: Evaluation of Dosimetry, Safety, Biodistribution and Preliminary Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-03
Completion Date
2026-08
Last Updated
2026-03-12
Healthy Volunteers
Yes
Conditions
Interventions
⁶⁸Ga-FC516
Healthy subjects will receive ⁶⁸Ga-FC516 injection followed by PET/CT scans at multiple timepoints post-administration.
⁶⁸Ga-FC516 and ⁶⁸Ga-labeled PSMA-targeting tracer
Patients with prostate cancer will undergo both ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled PSMA-targeting tracer PET/CT scans with a minimum interval of 24 hours and a maximum of 14 days between the two.
⁶⁸Ga-FC516 and ⁶⁸Ga-labeled ACP3-targeting tracer
Patients with prostate cancer will undergo both ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled ACP3-targeting tracer PET/CT scans with a minimum interval of 24 hours and a maximum of 14 days between the two.
Locations (1)
The first affiliated hospital of Jinan University
Guangzhou, Guangdong, China