The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
Recruiting
Early Phase 1Interventional Study
Healthy AdultProstate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
10 (estimated)
Sponsor
FindCure Biosciences (ZhongShan) Co., Ltd. · Industry
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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…
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.
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