The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ⁶⁸Ga-FC516, ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer.
- Who it may be relevant to
- Registry conditions: Healthy Adult, Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Dosimetry, Safety, Biodistribution and Preliminary Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
Overview
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.
Interventions
- Drug ⁶⁸Ga-FC516
Healthy subjects will receive ⁶⁸Ga-FC516 injection followed by PET/CT scans at multiple timepoints post-administration. - Drug 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.
Primary outcome measures
- Frequency of adverse events (AEs) and SAEs [Time frame: Approximately 6 months]
- Standard uptake value (SUV) of tumors [Time frame: Approximately 6 months]
- Human dosimetry [Time frame: Approximately six months]
Secondary outcome measures (1)
- Tumor detection rate [Time frame: Approximately six months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- The first affiliated hospital of Jinan University — Guangzhou
Identifiers
NCT: NCT07468708 · FC516-IIT-01