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NCT Number: NCT05865054

Vascular MRI Evaluation in Giant Cell Arteritis (VEGA)

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).

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Key information

Conditions

Giant Cell Arteritis Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Immune System Diseases Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Diagnostic Test

Combined orbital and cranial vessel wall MRI

Primary outcomes

  1. Vessel Wall Enhancement Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brenda Hernandez-Romero, B.S

CONTACT

[email protected]

917-548-2067

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Acronym: VEGA

Important dates

Study start
2020
Primary completion
2030
Study completion
2033
First posted
May 18, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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