Vessel Wall Enhancement in Giant Cell Arteritis

Giant Cell Arteritis Clinical Trial

— VEGA  

Official title:

Vessel Wall Enhancement in Giant Cell Arteritis: The VEGA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865054
• Other study ID #: 843171
• Status: Recruiting
• Start date: July 29, 2020
• Est. completion date: July 2026

Study information

• Verified date: June 2024
• Source: University of Pennsylvania
• Contact: Rui Liang, B.S
• Phone: 585-766-8604
• Email: rui.liang[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 diagnosed with giant cell arteritis (GCA; temporal arteritis).

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 1-month, 6-months, 12-months after the initial MRI scan or at the time of relapse.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Participant must be in one of the following groups:

1. Suspected new diagnosis of GCA

2. Suspected relapse of GCA (new or worsening symptoms attributed to active GCA) in patient with previously established diagnosis of GCA

• The participant must have (or previously had) cranial manifestations related to or concerning for GCA including: visual symptoms, headache, temporal artery tenderness, jaw claudication, scalp tenderness, or stroke

• Participant must be within 14 days of initiating or escalating systemic glucocorticoids (e.g., prednisone) OR have ongoing cranial symptoms concerning for active disease at time of baseline MRI.

• Participants who are receiving a clinically-indicated MRI at the time of enrollment may participate even if they meet exclusion criteria of creatinine clearance less than 30 ml/min or mild gadolinium allergy

• Participants must sign the informed consent form

Exclusion Criteria:

• Contra-indication to receiving MRI including:

• Implanted medical devices, pacemaker and metallic foreign fragments inside body or orbit

• Known gadolinium allergy

• Estimated glomerular filtration rate less than 30 ml/min/1.73m2

• Claustrophobia

• Women who are pregnant or nursing

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Diagnostic Test:
• Magnetic Resonance Imaging (MRI)
Combined orbital and cranial vessel wall MRI

Locations

Country	Name	City	State
United States	3400 Civic Center Blvd	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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