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Hippocrates: FAPI-PET/CT and FDG-PET/CT in Peyronie's Disease
NCT07903987Phase 4
Key facts
- Status
- Recruiting
- Start
- Dec 2024
- Primary completion
- Aug 2027
- Countries
- 1
- Sponsor
- University Medical Center Groningen
- Drugs
- 68Ga-FAPI
- Conditions
- Peyronie's disease
01
Overview
Phase 4, open-label, single-arm trial of 68Ga-FAPI in Peyronie's disease, sponsored by University Medical Center Groningen. Primary endpoint: Detection of active fibroblasts and/or inflammation. Started Dec 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Pilot study, only 1 arm
All participants receive 68Ga-FAPI (200 MBq) for FAPI-PET/CT scan and also undergo an FDG-PET/CT scan.
03
Who it enrols
Men >18 years with acute (<6 months, painful) or chronic (>=6 months, stable, no pain) Peyronie's disease, excluding those with other malignancies or prior PD treatments.
04
Endpoints
Primary
Detection of active fibroblasts and/or inflammation
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