Recruiting

Inflammation Imaging

Sponsor:

University of Pennsylvania

Code:

NCT05865054

Conditions

Giant Cell Arteritis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Magnetic Resonance Imaging (MRI)

Study Details

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).

Conditions

Giant Cell Arteritis

Study ID

NCT05865054

Start date

Jul 29, 2020

Status verified date

Sep, 2025

Completion date

Jul, 2033

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Ocular GCA

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

Non-Ocular GCA

GCA without ocular manifestations

Non-GCA

Initially suspected to have GCA but final clinical diagnosis not GCA

Interventions

Magnetic Resonance Imaging (MRI)

Combined orbital and cranial vessel wall MRI

Primary outcome measure

  • Vessel Wall Enhancement Score [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Brenda Hernandez-Romero, B.S

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

Locations

Mayo Building and Gonda Building

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jennifer Sletten

507-284-3695sletten.jennifer@mayo.edu

3400 Civic Center Blvd

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Brenda Hernandez-Romero, B.S

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

Principal Investigator:

Rennie Rhee, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Keywords

  • Temporal Arteritis
  • Horton's Giant Cell Arteritis
  • Horton's Disease
  • Horton Giant Cell Arteritis
  • Horton Disease
  • Cranial Arteritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-09-19.