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NCT Number: NCT07468708

The Dosimetry, Safety and 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.

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Key information

Conditions

Healthy Adult Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

The first affiliated hospital of Jinan University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Lu Wang, Doctor

CONTACT

[email protected]

020-36868405

Lu Wang, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

⁶⁸Ga-FC516

Drug

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

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.

Primary outcomes

  1. Frequency of adverse events (AEs) and SAEs

    Time frame: Approximately 6 months

  2. 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

  3. Human dosimetry

    Time frame: Approximately six months

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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tingjin Wang

CONTACT

[email protected]

18664044814

Sponsors and collaborators

Lead sponsor

FindCure Biosciences (ZhongShan) Co., Ltd.

Industry

Collaborators

  • First Affiliated Hospital of Jinan University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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