Vessel Wall Enhancement in Giant Cell Arteritis

Recruiting

• Conditions: Giant Cell Arteritis
• Interventions: Diagnostic Test: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT05865054
• Lead Sponsor: University of Pennsylvania

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

Study Timeline

• Study Start: 2020-07-29
• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-11
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Ocular GCA	Magnetic Resonance Imaging (MRI)	GCA without ocular manifestations
Non-GCA	Magnetic Resonance Imaging (MRI)	Initially suspected to have GCA but final clinical diagnosis not GCA
Ocular GCA	Magnetic Resonance Imaging (MRI)	GCA with clinical diagnosis of ischemic optic neuropathy or other ocular condition

Primary Outcome Measures

Name	Time	Method
Vessel Wall Enhancement Score	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.

Trial Locations

Locations (1)

3400 Civic Center Blvd; 🇺🇸 Philadelphia, Pennsylvania, United States