Vascular MRI Evaluation in Giant Cell Arteritis (VEGA) (VEGA)

A Longitudinal Study of Orbital and Cranial Vessel Wall MRI in Giant Cell Arteritis by the Vascular MRI Evaluation in Giant Cell Arteritis (VEGA) Collaborative

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).

Study Overview

• Status: Recruiting
• Conditions: Giant Cell Arteritis
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Imaging (MRI)

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Brenda Hernandez-Romero, B.S; Phone Number: 917-548-2067; Email: Brenda_Hernandez-Romero@pennmedicine.upenn.edu

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8G 5E4
      • Not yet recruiting
      • St. Joseph's Healthcare Hamilton
      • Contact: Sandra Messier; Phone Number: 905-573-4823; Email: smessier@stjosham.on.ca
• Germany
  • Würzburg
    • Würzburg, Würzburg, Germany, 97080
      • Not yet recruiting
      • University Hospital Wuerzburg
      • Contact: Carmen Müglich; Phone Number: 49 931 201 40112; Email: Mueglich_C@ukw.de
• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Building and Gonda Building
      • Contact: Jennifer Sletten; Phone Number: 507-284-3695; Email: sletten.jennifer@mayo.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • 3400 Civic Center Blvd
      • Principal Investigator: Rennie Rhee, MD
      • Contact: Brenda Hernandez-Romero, B.S; Phone Number: 917-548-2067; Email: Brenda_Hernandez-Romero@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the ambulatory clinic, emergency department, or inpatient settings.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ocular GCA; GCA with clinical diagnosis of ischemic optic neuropathy or other ocular condition	Diagnostic test: Magnetic Resonance Imaging (MRI); Combined orbital and cranial vessel wall MRI
Non-Ocular GCA; GCA without ocular manifestations	Diagnostic test: Magnetic Resonance Imaging (MRI); Combined orbital and cranial vessel wall MRI
Non-GCA; Initially suspected to have GCA but final clinical diagnosis not GCA	Diagnostic test: Magnetic Resonance Imaging (MRI); Combined orbital and cranial vessel wall MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vessel Wall Enhancement Score	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Rennie Rhee, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2033

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Temporal Arteritis; Horton's Giant Cell Arteritis; Horton's Disease; Horton Giant Cell Arteritis; Horton Disease; Cranial Arteritis
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Skin Diseases; Skin Diseases, Vascular; Vasculitis; Vasculitis, Central Nervous System; Arteritis; Skin and Connective Tissue Diseases; Giant Cell Arteritis; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging
• Other Study ID Numbers: 843171; R01AR084199-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This has not been approved by the ethics committee at some sites.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No