Using MRI to detect inflammation in giant cell arteritis
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
This study is testing if MRI scans can help find inflammation in the arteries of people with giant cell arteritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 4 sites (Rochester, Minnesota and 3 other locations) |
| Trial ID | NCT05865054 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of magnetic resonance imaging (MRI) in identifying inflammation in the arteries that supply blood to the head, brain, and eyes in patients diagnosed with giant cell arteritis (GCA). Participants will undergo an MRI scan within two weeks of enrollment and complete questionnaires about their condition. Follow-up visits and additional MRI scans may be conducted at 1 month, 6 months, and 12 months after the initial scan or during a relapse of symptoms.
Who should consider this trial
Good fit: Ideal candidates include individuals with a suspected new diagnosis or relapse of giant cell arteritis who exhibit cranial symptoms.
Not a fit: Patients without cranial manifestations or those who do not meet the inclusion criteria for GCA may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnosis and management of giant cell arteritis by providing a non-invasive method to detect arterial inflammation.
How similar studies have performed: While the use of MRI in this context is promising, it is a relatively novel approach and further validation is needed to establish its effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Rochester, Minnesota and 3 other locations
- Mayo Building and Gonda Building — Rochester, Minnesota, United States (Recruiting)
- 3400 Civic Center Blvd — Philadelphia, Pennsylvania, United States (Recruiting)
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Not_yet_recruiting)
- University Hospital Wuerzburg — Würzburg, Würzburg, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Rennie Rhee, MD — University of Pennsylvania
- Study coordinator: Brenda Hernandez-Romero, B.S
- Email: Brenda_Hernandez-Romero@pennmedicine.upenn.edu
- Phone: 917-548-2067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.