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RECRUITING
NCT06335888
PHASE2

A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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

Interventions

DRUG

AzaFol

AzaFol-PET/CT imaging

DRUG

FDG

FDG-PET/CT imaging

Locations (1)

Department of Rheumatology and Immunology, University Hospital Bern, Inselspital

Bern, Switzerland