Actively Recruiting
A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-01
70
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
P
Paul Scherrer Institut, Center for Proton Therapy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 50 years or older with clinical suspicion of giant cell arteritis
- Women of childbearing potential must have a negative serum pregnancy test at screening
- Able to understand and follow all study requirements and provide informed consent
- Willing and able to comply with all study procedures
You will not qualify if you...
- Folate deficiency
- Pregnant, breastfeeding, or planning to become pregnant during the study or within 30 days after last dose
- Taking medications that significantly reduce folic acid levels (methotrexate, pemetrexed, raltitrexed)
- Receiving glucose-containing infusion or parental nutrition within 6 hours before 2-[18F]FDG tracer application
- Blood glucose level above 10 mmol/l at time of 2-[18F]FDG PET/CT
- Unable to remain in the PET/CT scanner for the full examination time
- Unable to lie still for about 45 minutes during the examination
- Unable to fast (no food or drink except water) for 6 hours before 2-[18F]FDG tracer application
- PET imaging within 60 days before baseline
- Taking vitamin supplements with more than 1 mg/day folic acid within 48 hours before AzaFol PET/CT
- Known allergy or hypersensitivity to folic acid
- Investigator or related persons enrolled in the study
- Participation in another investigational drug study within 7 days before and during this study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Rheumatology and Immunology, University Hospital Bern, Inselspital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
B
Britta Maurer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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