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

April 24, 2026 updated by: FindCure Biosciences (ZhongShan) Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Jinan University
        • Contact:
        • Principal Investigator:
          • Lu Wang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ⁶⁸Ga-FC516 PET/CT
Drug: ⁶⁸Ga-FC516
Healthy subjects will receive ⁶⁸Ga-FC516 injection followed by PET/CT scans at multiple timepoints post-administration.
Experimental: ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT
Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor detection rate
Time Frame: Approximately six months
Compare the tumor detection rate between 68Ga-FC516 PET/CT and 68Ga-labeled prostate cancer-targeting tracer PET/CT.
Approximately six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FindCure Biosciences (ZhongShan) Co., Ltd.

Collaborators

First Affiliated Hospital of Jinan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FC516-IIT-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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