Vessel Wall Enhancement in Giant Cell Arteritis

Study Overview
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Brief Summary
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The research study is being conducted to determine the utility of magnetic resonance imaging (MRI) in identifying inflammation of arteries supplying blood to the head, brain, and eyes. The target population includes patient diagnosed with giant cell arteritis (GCA; temporal arteritis).

Detailed Description
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After signing the consent form, participants will complete an MRI scan within 2 weeks of enrollment and fill out questionnaires related to their disease. Follow up visits and MRI scans may occur at 1-month, 6-months, 12-months after the initial MRI scan or at the time of relapse.

Official Title
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Vessel Wall Enhancement in Giant Cell Arteritis: The VEGA Study

Conditions
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Giant Cell Arteritis

Intervention / Treatment
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* Diagnostic Test: Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be in one of the following groups: Suspected new diagnosis of GCA Suspected relapse of GCA (new or worsening symptoms attributed to active GCA) in patient with previously established diagnosis of GCA The participant must have (or previously had) cranial manifestations related to or concerning for GCA including: visual symptoms, headache, temporal artery tenderness, jaw claudication, scalp tenderness, or stroke Participant must be within 14 days of initiating or escalating systemic glucocorticoids (e.g., prednisone) OR have ongoing cranial symptoms concerning for active disease at time of baseline MRI. Participants who are receiving a clinically-indicated MRI at the time of enrollment may participate even if they meet exclusion criteria of creatinine clearance less than 30 ml/min or mild gadolinium allergy Participants must sign the informed consent form Exclusion Criteria: Contra-indication to receiving MRI including: Implanted medical devices, pacemaker and metallic foreign fragments inside body or orbit Known gadolinium allergy Estimated glomerular filtration rate less than 30 ml/min/1.73m2 Claustrophobia Women who are pregnant or nursing

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ocular GCA<br>GCA with clinical diagnosis of ischemic optic neuropathy or other ocular condition | Diagnostic Test: Magnetic Resonance Imaging (MRI)<br>* Combined orbital and cranial vessel wall MRI<br>|
| Non-Ocular GCA<br>GCA without ocular manifestations | Diagnostic Test: Magnetic Resonance Imaging (MRI)<br>* Combined orbital and cranial vessel wall MRI<br>|
| Non-GCA<br>Initially suspected to have GCA but final clinical diagnosis not GCA | Diagnostic Test: Magnetic Resonance Imaging (MRI)<br>* Combined orbital and cranial vessel wall MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI enhancement score | Enhancement of cranial vessel wall, orbital structures, or other cranial structures | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temporal Arteritis, Juvenile Temporal Arteritis, Horton's Giant Cell Arteritis, Horton's Disease, Horton Giant Cell Arteritis, Horton Disease, Giant Cell Aortitis, Giant Cell Aortic Arteritis, Cranial Arteritis