Use of MRI and PET for Assessing Disease Activity in Takayasu's Arteritis

Sponsor

Peter Merkel (Other)

Overall Status

Completed

CT.gov ID

NCT00744952

Collaborator

Office of Rare Diseases (ORD) (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), Rare Diseases Clinical Research Network (Other)

Enrollment

Locations

122

Actual Duration (Months)

5.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assessing disease activity in people with Takayasu's arteritis is difficult, as most people with the disease do not exhibit visible, measurable symptoms. Combination positron emission tomography/computed axial tomography (PET/CT) is a particularly sensitive, accurate scanning method that may improve researchers' ability to evaluate people with the disease. This study will determine the effectiveness of PET/CT in assessing disease activity in people with Takayasu's arteritis.

Condition or Disease	Intervention/Treatment	Phase
Takayasu Arteritis

Detailed Description

Takayasu's arteritis is a rare inflammatory disease that affects the aorta and its branches. The disease is much more common in females than in males, and disease onset typically occurs between the ages of 15 and 30. People with this disease often experience general discomfort, fatigue, fever, night sweats, weight loss, and joint pain. In the late stages of the disease, weak arterial walls may lead to aneurysms. Many patients do not exhibit any visible symptoms until this point, however. Because many people with Takayasu's arteritis do not have overt disease symptoms, the assessment of disease activity is difficult. Laboratory tests can help, but are often unreliable. Novel approaches to assessing disease activity are urgently needed to enhance and facilitate research on Takayasu's arteritis. This study will determine the effectiveness of combination positron emission tomography/computed axial tomography (PET/CT) in assessing disease activity in people with Takayasu's arteritis.

Participants in this study will enroll while their disease is active. The first PET/CT scan will take place upon study entry, while there is active disease. Participants will have a second PET/CT scan 3 months later, and a third scan 3 months after that if there is still active disease present. Participants will have a maximum of 3 scans unless a scan needs to be repeated because of technical failures, though this does not often happen. If there is no active disease at the time of the second scan, a third scan will not be done. All PET/CT scans will be scheduled within 10 days of participants' routine MRI scans. This study will not require any follow-up visits.

Study Design

Study Type:

Observational

Actual Enrollment :

26 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

VCRC Imaging Protocol for Magnetic Resonance and Positron Emission Tomography in Large-vessel Vasculitis (Takayasu's Arteritis):Development as Clinical Trial Outcome Measures

Actual Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Sep 30, 2018

Actual Study Completion Date :

Sep 30, 2018

Outcome Measures

Primary Outcome Measures

Disease activity [Measured throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of Takayasu's arteritis, as defined by the VCRC Longitudinal Study #5503
Currently enrolled in the VCRC Longitudinal Study #5503
Active disease has occurred in conjunction with a disease relapse within 2 weeks before study entry (A detailed definition of "active disease" is available in the study protocol.)
Willing and able to comply with the schedule for imaging studies and follow-up procedures

Exclusion Criteria:

Pregnant or breastfeeding
Unable to comply with study guidelines
Unable to safely undergo MRI scanning

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston University School of Medicine	Boston	Massachusetts	United States	02118
2	Mayo Clinic	Rochester	Minnesota	United States	55905
3	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
4	St. Joseph's Healthcare	Hamilton	Ontario	Canada
5	Mount Sinai Hospital, Toronto	Toronto	Ontario	Canada	M5L 3L9