Clinical trial · Interventional
The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
Evaluation of Dosimetry, Safety, Biodistribution and Preliminary Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Adult | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ⁶⁸Ga-FC516 | Drug | — | UNRESOLVED |
| ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ⁶⁸Ga-FC516 PET/CT
- interventionNames
- Drug: ⁶⁸Ga-FC516
- type
- EXPERIMENTAL
- label
- ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT
- interventionNames
- Drug: ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer
Primary outcomes (3)
- measure
- Frequency of adverse events (AEs) and SAEs
- timeFrame
- Approximately 6 months
- measure
- Standard uptake value (SUV) of tumors
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available