Vascular MRI Evaluation in Giant Cell Arteritis (VEGA)

Recruiting

• Conditions: Giant Cell Arteritis

• Registration Number: NCT05865054
• Lead Sponsor: University of Pennsylvania

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2020-07-29
• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-07-01
• Primary Completion: 2030-07
• Study Completion: 2033-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vessel Wall Enhancement Score	Up to 12 months	Enhancement of cranial vessel wall, orbital structures, or other cranial structures. Scores range from 0 to 3; 0 being no inflammation and 3 being more enhancement or inflammation.

Trial Locations

Locations (1)

3400 Civic Center Blvd; 🇺🇸 Philadelphia, Pennsylvania, United States