Phase II Open-Label Study Comparing 18F-AzaFol and FDG PETCT Imaging for Diagnosing Giant Cell Arteritis in Adults Aged 50 and Older

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 PETCT scans to diagnose GCA. Researchers aim to compare AzaFol with the standard 2-18FFDG-PETCT 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-PETCT and FDG-PETCT 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.

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