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

NCT07468708 | Recruiting Early Phase 1

• 1 other identifier: FC516-IIT-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult; Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Frequency of adverse events (AEs) and SAEs

  Approximately 6 months

• Standard uptake value (SUV) of tumors

  Compare the SUV of tumor between 68Ga-FC516 PET/CT and 68Ga-labeled prostate cancer-targeting tracer PET/CT

  Approximately 6 months

• Human dosimetry

  Radiation dose to individual organs and the equivalent dose for the whole body of each subject.

  Approximately six months

Secondary Outcomes (1)

• Tumor detection rate

  Approximately six months

Study Arms (2)

⁶⁸Ga-FC516 PET/CT

EXPERIMENTAL

Drug: ⁶⁸Ga-FC516

⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT

EXPERIMENTAL

Drug: ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer

Interventions

⁶⁸Ga-FC516 DRUG

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

⁶⁸Ga-FC516 PET/CT

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

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.

⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• FindCure Biosciences (ZhongShan) Co., Ltd.: lead
• First Affiliated Hospital of Jinan University: collaborator

Study Sites (1)

The first affiliated hospital of Jinan University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Tingjin Wang

CONTACT

18664044814; wangtingjin@find-cure.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-03

Locations

CN (1)