Giant Cell Arteritis Vessel Wall Enhancement
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-001667
About this study
The purpose of this study is to determine the utility of vessel wall enhancement seen on high-resolution MRI in the diagnosis, prognosis, and treatment management of giant cell arteritis (GCA). Also, to evaluate the association between ophthalmic artery and perineural optic nerve sheath enhancement on MRI and diagnosis and outcomes in GCA.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- ≥ 50 years of age.
- Participant must be in one of the following groups:
- Suspected new diagnosis of GCA;
- 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/1.73m^2.
- Claustrophobia.
- Women who are pregnant or nursing.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 2/14/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kenneth Warrington, M.D. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available