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

FindCure Biosciences

Status and phase: Enrolling; Early Phase 1

Conditions: Healthy Adult; Prostate Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07468708

FC516-IIT-01

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

⁶⁸Ga-FC516 PET/CT

Experimental group

Treatment:

Drug: ⁶⁸Ga-FC516

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

Experimental group

Treatment:

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