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

Recruiting Phase 2 Interventional Study
Giant Cell Arteritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
70 (estimated)
Sponsor
Insel Gruppe AG, University Hospital Bern · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 info…
Contacts

Britta Maurer

+41 31 63 2 7229

RI-Studien@insel.ch

CONTACT