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A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
Sponsor: Insel Gruppe AG, University Hospital Bern
Summary
The goal of this open-label clinical trial is to evaluate the efficacy of AzaFol-PET/CT in the diagnosis of GCA (giant cell arteritis), to compare AzaFol- with 2-\[18F\]FDG-PET/CT, and to assess the safety and tolerability of AzaFol in subjects with suspicion of GCA. Participants will undergo AzaFol-PET/CT imaging at a single timepoint.
Official title: Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2025-02-03
Completion Date
2029-05
Last Updated
2025-02-13
Healthy Volunteers
No
Conditions
Interventions
AzaFol
AzaFol-PET/CT imaging
FDG
FDG-PET/CT imaging
Locations (1)
Department of Rheumatology and Immunology, University Hospital Bern, Inselspital
Bern, Switzerland