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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/21/2018
Start Date:August 2008
End Date:September 30, 2018

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

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.

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.

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
We found this trial at
4
sites
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Carol Langford, MD, MHS
Phone: 216-445-1397
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Principal Investigator: Paul Monach, MD, PhD
Phone: 617-414-2512
Boston University School of Medicine A leader in medical education and research, Boston University School...
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Boston, MA
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Hamilton, Ontario
Principal Investigator: Nader Khalidi, MD, FRCPC
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Hamilton,
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Rochester, Minnesota 55905
Principal Investigator: Steven Ytterberg, MD
Phone: 507-284-4502
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Rochester, MN
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