Vascular MRI Evaluation in Giant Cell Arteritis (VEGA)

University of Pennsylvania

Status: Enrolling

Conditions: Giant Cell Arteritis

Treatments: Diagnostic Test: Magnetic Resonance Imaging (MRI)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05865054

R01AR084199-01A1 (U.S. NIH Grant/Contract)

843171

Details and patient eligibility

About

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 with suspected giant cell arteritis (GCA; temporal arteritis).

Full description

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 6-months after the initial MRI scan or at the time of relapse.

Enrollment: 400 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 50 years or older
• First presentation of suspected GCA
• New or worsening cranial manifestations within 4 weeks of enrollment concerning for active GCA
• Elevated CRP greater than 1.0 mg/dl
• Plan to undergo temporal artery biopsy or ultrasound for diagnosis

Exclusion criteria

• Contra-indication to receiving MRI including:

Implanted medical devices, pacemaker, and metallic foreign fragments inside body/orbits Known gadolinium allergy Women who are pregnant or nursing

• Absence of cranial symptoms related to GCA (e.g., only large vessel GCA)

Trial design

400 participants in 3 patient groups

Ocular GCA

Description:

GCA with clinical diagnosis of ischemic optic neuropathy or other ocular condition

Treatment:

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Non-Ocular GCA

Description:

GCA without ocular manifestations

Treatment:

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Non-GCA

Description:

Initially suspected to have GCA but final clinical diagnosis not GCA

Treatment:

Diagnostic Test: Magnetic Resonance Imaging (MRI)