Giant Cell Arteritis Clinical Trial
Official title:
Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
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.
Giant cell arteritis (GCA) is the most common systemic vasculitis in the elderly population. 2-[18F]Fluor-2-desoxy-D-glucose (2-[18F]FDG) positron emission tomography (PET)/ computed tomography (CT) is performed to diagnose GCA (standard of care, SOC) but unable to reliably distinguish atherosclerosis from vasculitis. Activated macrophages express folate receptor (FR)-β and are enriched in inflamed vascular tissue in GCA. 3'-Aza-2'-[18F]Fluoro-Folic Acid (AzaFol) is a nuclear tracer targeting FRβ. The investigators hypothesize that AzaFol is a specific and reliable tracer to visualize activated macrophages in GCA and therefore might improve the discrimination of vasculitic and atherosclerotic lesions as compared to 2-[18F]FDG-PET/CT. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03812302 -
Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)
|
Phase 2 | |
| Recruiting |
NCT02257866 -
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
|
||
| Recruiting |
NCT04888221 -
Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement
|
Phase 3 | |
| Recruiting |
NCT05380453 -
Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission
|
Phase 3 | |
| Recruiting |
NCT02333708 -
Study of Circulating Microparticles in Giant Cell Arteritis
|
||
| Completed |
NCT01450137 -
Tocilizumab for Patients With Giant Cell Arteritis
|
Phase 2 | |
| Completed |
NCT03827018 -
KPL-301 for Subjects With Giant Cell Arteritis
|
Phase 2 | |
| Active, not recruiting |
NCT04519580 -
Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
|
||
| Recruiting |
NCT04239196 -
Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA
|
Phase 2 | |
| Recruiting |
NCT06460142 -
Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
|
||
| Completed |
NCT03202368 -
An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)
|
Phase 3 | |
| Not yet recruiting |
NCT02523625 -
Giant Cell Arteritis: Improving Use of Ultrasound Evaluation
|
N/A | |
| Completed |
NCT03285945 -
FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment
|
N/A | |
| Completed |
NCT02190916 -
Vasculitis Illness Perception (VIP) Study
|
N/A | |
| Recruiting |
NCT01241305 -
One-Time DNA Study for Vasculitis
|
||
| Terminated |
NCT02531633 -
Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
|
Phase 3 | |
| Completed |
NCT03765424 -
Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis
|
||
| Completed |
NCT03409913 -
Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA
|
N/A | |
| Completed |
NCT01910038 -
Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.
|
Phase 2 | |
| Not yet recruiting |
NCT04012905 -
Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering
|
Phase 3 |