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Clinical Trials in the EU / 2025-523880-39-02
Authorised, recruiting Phase III

A novel fibroblast imaging biomarker and ultrahigh resolution PET to improve the diagnosis and follow-up of giant cell arteritis

2025-523880-39-02 · tracked via the Priya Life Science EU tracker
Sponsor
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Cardiovascular Diseases
Decision date
09/02/2026
Enrollment target
60
Sites
Belgium

Condition studied

Giant Cell Arteritis

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Ability to visualize activate arteritis of the ophthalmic artery. Diagnostic accuracy (AUC – combined sensitivity and specifity) of FDG and FAPI PET for diagnosing GCA. Ability to visualize to identify chronic pathological fibroblast activation on FAPI PET. Demontsrate a correlation between FAP+ fibroblast cell state and FAPI PET parameters at clinical diagnosis and remission. Additional primary endpoints related to the clinical investigational NeuroEXPLORER device : See Master Protocol

Endpoint detail

To distinguish GCA from non-GCA causes in patients presenting with vision loss. . To evaluate the evolution of FAPI and FDG uptake from active disease to remission. To identify other import cell types in the pathogenesis of GCA using single nuclei RNA sequencing. Additional secondary endpoints related to the clinical investigational NeuroEXPLORER device: See Master Protocol EUDAMED_ CIV-25-06-053398.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523880-39-02 on CTIS ↗ ← All trials in the EU