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

NCT06335888 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Giant Cell Arteritis

Interventions

DRUG

AzaFol

AzaFol-PET/CT imaging

DRUG

FDG

FDG-PET/CT imaging

Sponsors & Collaborators

  • Paul Scherrer Institut, Center for Proton Therapy

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Britta Maurer · Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2029-05-31
Completion
2029-05-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06335888 on ClinicalTrials.gov