NCT05865054

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 with suspected giant cell arteritis (GCA; temporal arteritis).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
87mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Jul 2020Jul 2033

Study Start

First participant enrolled

July 29, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2033

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

9.9 years

First QC Date

May 9, 2023

Last Update Submit

September 15, 2025

Conditions

Giant Cell Arteritis

Keywords

Temporal ArteritisHorton's Giant Cell ArteritisHorton's DiseaseHorton Giant Cell ArteritisHorton DiseaseCranial Arteritis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Ocular GCA

GCA with clinical diagnosis of ischemic optic neuropathy or other ocular condition

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Non-Ocular GCA

GCA without ocular manifestations

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Non-GCA

Initially suspected to have GCA but final clinical diagnosis not GCA

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Interventions

Magnetic Resonance Imaging (MRI)DIAGNOSTIC_TEST

Combined orbital and cranial vessel wall MRI

Non-GCANon-Ocular GCAOcular GCA

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from the ambulatory clinic, emergency department, or inpatient settings.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Building and Gonda Building

Rochester, Minnesota, 55905, United States

RECRUITING

3400 Civic Center Blvd

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8G 5E4, Canada

NOT YET RECRUITING

University Hospital Wuerzburg

Würzburg, Würzburg, 97080, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Rennie Rhee, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda Hernandez-Romero, B.S

CONTACT

917-548-2067Brenda_Hernandez-Romero@pennmedicine.upenn.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 18, 2023

Study Start

July 29, 2020

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2033

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

This has not been approved by the ethics committee at some sites.

Locations

CA(1)DE(1)US(2)