Clinical Trial Finder

Vessel Wall Enhancement in Giant Cell Arteritis

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 50 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05865054
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Pennsylvania
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Rennie Rhee, MD
Principal Investigator Affiliation University of Pennsylvania
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Giant Cell Arteritis
Additional Details

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.

Arms & Interventions

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

Diagnostic Test: - Magnetic Resonance Imaging (MRI)

Combined orbital and cranial vessel wall MRI

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

3400 Civic Center Blvd, Philadelphia, Pennsylvania

Status

Recruiting

Address

3400 Civic Center Blvd

Philadelphia, Pennsylvania, 19104

Site Contact

Rui Liang, B.S

[email protected]

585-766-8604

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