A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
Recruiting now · Phase 2
Conditions studied: Giant Cell Arteritis
In brief
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.
Key facts
- Study ID
- NCT06335888
- Run by
- Insel Gruppe AG, University Hospital Bern
- People needed
- 70
- Starts
- 2025-02-03
- Expected to finish
- 2029-05-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Individuals ≥ 50 years with clinical suspicion of GCA
- Women of childbearing potential must not have a positive serum pregnancy test at the Screening Visit
- Subjects must be able to understand and adhere to all protocol requirements and must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- Are willing and able to comply with procedures required in this protocol.
You may not qualify if…
- Folate deficiency
- Female subjects who are pregnant, breastfeeding, or considering becoming pregnant during the study or within 30 days after the last dose of study drug
- Concomitant treatment with medications that lead to a significant impairment of folic acid levels (methotrexate, pemetrexed, raltitrexed)
- Concomitant glucose-containing infusion or parental nutrition within 6 hours prior to 2-[18F]FDG tracer application
- Glucose level > 10 mmol/l at the timepoint of 2-[18F]FDG PET/CT
- Unable to remain in the PET/CT for the duration of the examination
- Unable to lie still for the duration of the examination (45 min)
- Unable not to eat or drink (except water) for 6 hours prior to 2-[18F]FDG tracer application
- Prior PET-imaging within 60 days before baseline
- Intake of vitamin supplements containing > 1mg/day folic acid within 48 h prior to the PET/CT with AzaFol
- Known hypersensitivity or allergy to folic acid
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Participation in another study with investigational drug within the 7 days preceding and during the present study.
Where it is running
- Department of Rheumatology and Immunology, University Hospital Bern, Inselspital — Bern, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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