Giant Cell ArteritisVEGANCT05865054
Vascular MRI Evaluation in Giant Cell Arteritis (VEGA)
An observational study of Giant Cell Arteritis, run by University of Pennsylvania at 4 sites in 3 countries.
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 with suspected giant cell arteritis (GCA; temporal arteritis). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- How many people
- 400 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 29 Jul 2020to Jul 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the ambulatory clinic, emergency department, or inpatient settings.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
United States2 sites, 2 recruiting
- Recruiting
3400 Civic Center Blvd
Philadelphia, Pennsylvania, 19104
Brenda Hernandez-Romero, B.S, 917-548-2067, Brenda_Hernandez-Romero@pennmedicine.upenn.edu
Rennie Rhee, MD
- Recruiting
Mayo Building and Gonda Building
Rochester, Minnesota, 55905
Jennifer Sletten, 507-284-3695, sletten.jennifer@mayo.edu
Canada1 site, 1 recruiting
- Not yet recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8G 5E4
Sandra Messier, 905-573-4823, smessier@stjosham.on.ca
Germany1 site, 1 recruiting
- Not yet recruiting
University Hospital Wuerzburg
Würzburg, Würzburg, 97080
Carmen Müglich, 49 931 201 40112, Mueglich_C@ukw.de
About this study
Official 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
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).
Read the 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 6-months after the initial MRI scan or at the time of relapse.
- Conditions
- Giant Cell Arteritis
- Being tested
- Magnetic Resonance Imaging (MRI)
- Keywords
- Temporal Arteritis, Horton's Giant Cell Arteritis, Horton's Disease, Horton Giant Cell Arteritis, Horton Disease, Cranial Arteritis
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Diagnostic test
Combined orbital and cranial vessel wall MRI
| Study group | Role | What they receive |
|---|---|---|
| Ocular GCA | GCA with clinical diagnosis of ischemic optic neuropathy or other ocular condition Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI) | |
| Non-Ocular GCA | GCA without ocular manifestations Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI) | |
| Non-GCA | Initially suspected to have GCA but final clinical diagnosis not GCA Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start29 Jul 2020
- Primary completionJul 2030 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Rennie Rhee, M.D., MSCE, University of Pennsylvania
- Investigators
- Rennie Rhee, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865054
- Sponsor's protocol ID
- 843171
- Other IDs
- R01AR084199-01A1
- Acronym
- VEGA
- Status last verified
- Sep 2026
- First submitted
- 9 May 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This has not been approved by the ethics committee at some sites.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05865054
- Acronym / sponsor ID
- VEGA / 843171
- Conditions
- Giant Cell Arteritis
- Keywords
- Temporal Arteritis, Horton's Giant Cell Arteritis, Horton's Disease, Horton Giant Cell Arteritis, Horton Disease, Cranial Arteritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 6-months after the initial MRI scan or at the time of relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ocular GCA | – | Diagnostic Test: Magnetic Resonance Imaging (MRI)GCA with clinical diagnosis of ischemic optic neuropathy or other ocular condition |
| Non-Ocular GCA | – | Diagnostic Test: Magnetic Resonance Imaging (MRI)GCA without ocular manifestations |
| Non-GCA | – | Diagnostic Test: Magnetic Resonance Imaging (MRI)Initially suspected to have GCA but final clinical diagnosis not GCA |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the ambulatory clinic, emergency department, or inpatient settings.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Combined orbital and cranial vessel wall MRI | Diagnostic test | Non-GCA, Non-Ocular GCA, Ocular GCA |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. This has not been approved by the ethics committee at some sites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rennie Rhee, MD principal investigator
University of Pennsylvania
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis, run by University of Pennsylvania at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brenda Hernandez-Romero, B.S (917-548-2067, Brenda_Hernandez-Romero@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel Wall Enhancement Score (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.