NCT06335888

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

Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Giant cell arteritis (GCA) is the most common systemic vasculitis in the elderly population. 2-\[18F\]Fluor-2-desoxy-D-glucose (2-\[18F\]FDG) positron emission tomography (PET)/ computed tomography (CT) is performed to diagnose GCA (standard of care, SOC) but unable to reliably distinguish atherosclerosis from vasculitis. Activated macrophages express folate receptor (FR)-β and are enriched in inflamed vascular tissue in GCA. 3'-Aza-2'-\[18F\]Fluoro-Folic Acid (AzaFol) is a nuclear tracer targeting FRβ. The investigators hypothesize that AzaFol is a specific and reliable tracer to visualize activated macrophages in GCA and therefore might improve the discrimination of vasculitic and atherosclerotic lesions as compared to 2-\[18F\]FDG-PET/CT.

Conditions

• Giant Cell Arteritis

Interventions

Type	Name	Description
DRUG	AzaFol	AzaFol-PET/CT imaging
DRUG	FDG	FDG-PET/CT imaging

Timeline

• Start date: 2025-02-03
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2024-03-28
• Last updated: 2025-02-13

Locations

1 site across 1 country: Switzerland