RecruitingPhase 2

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

Switzerland70 participantsStarted 2025-02-03

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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Exclusion criteria

✕. 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

What they're measuring

Specificity of the GCA-diagnosis at the patient level

Timeframe: Baseline

Trial details

NCT IDNCT06335888

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-05

Contact for this trial

Britta Maurer

+41 31 63 2 7229 RI-Studien@insel.ch

View on ClinicalTrials.gov More Giant Cell Arteritis trials