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Vascular MRI Evaluation in Giant Cell Arteritis (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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05865054
Acronym
VEGA
Enrollment
400
Registered
2023-05-18
Start date
2020-07-29
Completion date
2033-07-31
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis

Keywords

Temporal Arteritis, Horton's Giant Cell Arteritis, Horton's Disease, Horton Giant Cell Arteritis, Horton Disease, Cranial Arteritis

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.

Interventions

DIAGNOSTIC_TESTMagnetic Resonance Imaging (MRI)

Combined orbital and cranial vessel wall MRI

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Vessel Wall Enhancement ScoreUp to 12 monthsEnhancement 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.

Countries

Canada, Germany, United States

Contacts

Primary ContactBrenda Hernandez-Romero, B.S
Brenda_Hernandez-Romero@pennmedicine.upenn.edu917-548-2067

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026