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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07468708

Enrollment

Registered

2026-03-12

Start date

2026-03-09

Completion date

2026-10-01

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult, Prostate Cancer

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.

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

CONTACTTingjin Wang

wangtingjin@find-cure.com18664044814

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026