⁶⁸Ga-FC516⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer
⁶⁸Ga-FC516: 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: 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 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
The first affiliated hospital of Jinan University
Guangzhou
Guangdong
Recruiting
More FindCure Biosciences (ZhongShan) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.