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

ConditionsHealthy AdultProstate 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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: ⁶⁸Ga-FC516 PET/CTExperimental treatment 1 intervention
Group B: ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of adverse events (AEs) and SAEs

Time frame
Approximately 6 months
2

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

Time frame
Approximately 6 months
3

Human dosimetry

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

Time frame
Approximately six months

Secondary outcomes

1

Tumor detection rate

Compare the tumor detection rate between 68Ga-FC516 PET/CT and 68Ga-labeled prostate cancer-targeting tracer PET/CT.

Time frame
Approximately six months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

FindCure Biosciences (ZhongShan) Co., Ltd.

Lead sponsor

First Affiliated Hospital of Jinan University

Collaborator

Source ClinicalTrials.gov
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