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Sponsored by: |
Office of Rare Diseases (ORD) |
Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00744952 |
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 |
Takayasu Arteritis |
MedlinePlus related topics: | Vasculitis |
Study Type: | Observational |
Study Design: | Cohort, 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 |
Estimated Enrollment: | 36 |
Study Start Date: | August 2008 |
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 72 hours of participants' routine MRI scans. This study will not require any follow-up visits.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Participants in this study will have been diagnosed with Takayasu's arteritis and will be currently enrolled in the Vasculitis Clinical Research Consortium (VCRC) Longitudinal Study #5503.
Inclusion Criteria:
Exclusion Criteria:
Contact: Carol King, MA | 617-414-2505 | caking@bu.edu |
United States, Maryland | |||||
Johns Hopkins School of Medicine | Not yet recruiting | ||||
Baltimore, Maryland, United States, 21224 | |||||
Contact: Cynthia Bethea 410-550-4390 cbethea3@jhmi.edu | |||||
United States, Massachusetts | |||||
Boston University School of Medicine | Recruiting | ||||
Boston, Massachusetts, United States, 02118 | |||||
Contact: Jessica Martin 617-414-2507 jmartin@bu.edu | |||||
United States, Minnesota | |||||
Mayo Clinic | Not yet recruiting | ||||
Rochester, Minnesota, United States, 55905 | |||||
Contact: Jane Jaquith 507-284-4502 jaquith.jane@mayo.edu | |||||
United States, Ohio | |||||
Cleveland Clinic Foundation | Recruiting | ||||
Cleveland, Ohio, United States, 44195 | |||||
Contact: Katherine Tuthill 216-444-5257 tuthillk@ccf.org | |||||
Canada, Ontario | |||||
Mount Sinai Hospital, Toronto | Not yet recruiting | ||||
Toronto, Ontario, Canada, M5L 3L9 | |||||
Contact: Sara Sutherland 416-586-8616 SSutherland2@mtsinai.on.ca |
Principal Investigator: | Peter A. Merkel, MD, MPH | Boston University |
Principal Investigator: | Carol A. Langford, MD, MHS | The Cleveland Clinic |
Principal Investigator: | Phil Seo, MD, MHS | Johns Hopkins School of Medicine |
Principal Investigator: | Steve Ytterberg, MD | Mayo Clinic |
Principal Investigator: | Simon Carette, MD | Mount Sinai Hospital, Toronto |
Responsible Party: | Boston University School of Medicine ( Peter A. Merkel, MD, MPH ) |
Study ID Numbers: | RDCRN 5515 |
First Received: | August 29, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00744952 |
Health Authority: | United States: Federal Government |
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