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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorFindCure Biosciences (ZhongShan) Co., Ltd.

About this trial

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 criteria

Qualifiers

Voluntarily participate the clinical study; sign the informed consent form;

Aged 18 years or older;

Cohort A: Healthy subjects;

Cohort B: Patients with prostate cancer confirmed by histopathological or cytological diagnosis;

Disqualifiers

Severe impairment of liver, kidney, or cardiac function;

Severe obesity or other conditions that prevent or make PET/CT scanning impossible;

Hypersensitivity to any active or inactive components of the study drug;

Other subjects deemed unsuitable for enrollment by the investigators.

Trial design

Treatments tested in this trial

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

Treatment groups

10 Participants
are divided into 2 treatment groups

Sponsors and collaborators

FindCure Biosciences (ZhongShan) Co., Ltd.

Lead sponsor

First Affiliated Hospital of Jinan University

Collaborator