Actively Recruiting
Cross-over, Randomized, Open-label, Single-centre, Phase II 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
N/A
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
This clinical trial focuses on giant cell arteritis (GCA), a common systemic vasculitis affecting older adults. The study evaluates a new imaging tracer called AzaFol using PET/CT scans to diagnose GCA. Researchers aim to compare AzaFol with the standard 2-[18F]FDG-PET/CT imaging to determine if AzaFol better distinguishes inflammation caused by vasculitis from atherosclerosis. The trial also assesses the safety and tolerability of AzaFol in people suspected of having GCA. Participants will receive both AzaFol-PET/CT and FDG-PET/CT imaging in a randomized order. One group undergoes AzaFol imaging first followed by FDG, while the other group has FDG first then AzaFol. The study is open-label and randomized, with imaging performed at a single timepoint per participant to compare the two tracers directly. During the study, participants will be evaluated mainly by the imaging results to measure the specificity and sensitivity of GCA diagnosis using AzaFol compared to FDG. Researchers will also analyze lesion detection rates visually and semi-quantitatively. Safety and tolerability of AzaFol will be monitored, and participants must comply with protocol requirements, including fasting and remaining still during scans. The study participation duration for each person is centered around these imaging procedures and assessments.
CONDITIONS
Brief 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
- Ability to understand and follow all study procedures
- Voluntary signing of informed consent approved by ethics committee
- Willingness and ability to comply with all protocol requirements
You will not qualify if you...
- Folate deficiency
- Pregnancy, breastfeeding, or planning pregnancy during the study or within 30 days after last dose
- Taking medications that significantly lower folic acid levels (methotrexate, pemetrexed, raltitrexed)
- Receiving glucose-containing infusion or parenteral nutrition within 6 hours before FDG tracer application
- Blood glucose level above 10 mmol/l at FDG PET/CT timepoint
- Inability to remain in PET/CT scanner or lie still for 45 minutes
- Inability to fast (no food or drink except water) for 6 hours before FDG tracer application
- Prior PET imaging within 60 days before baseline
- Intake of 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
- Participation in another investigational drug study within 7 days before or during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline period
Participants undergo PET/CT imaging using two tracers, AzaFol and FDG, in a randomized order to diagnose giant cell arteritis and differentiate it from other conditions.
2 imaging visits
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
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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