RecruitingEarly Phase 1NCT07468708

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

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


Sponsor

FindCure Biosciences (ZhongShan) Co., Ltd.

Enrollment

10 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

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: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ⁶⁸Ga-FC516 and a drug called ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer for people with healthy adult and prostate cancer. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG⁶⁸Ga-FC516

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

DRUG⁶⁸Ga-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.


Locations(1)

The first affiliated hospital of Jinan University

Guangzhou, Guangdong, China

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NCT07468708


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