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

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ClinicalTrials.gov Identifier: NCT00744952
Recruitment Status : Recruiting
First Posted : September 1, 2008
Last Update Posted : May 2, 2017
Office of Rare Diseases (ORD)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Rare Diseases Clinical Research Network
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania

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
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 Type : Observational
Estimated Enrollment : 36 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 : August 2008
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis
U.S. FDA Resources

Primary Outcome Measures :
  1. Disease activity [ Time Frame: Measured throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744952

United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Naomi Amudala, NP    617-414-2512    namudala@bu.edu   
Principal Investigator: Paul Monach, MD, PhD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jane Jaquith    507-284-4502    jaquith.jane@mayo.edu   
Principal Investigator: Steven Ytterberg, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Katie Gartner    216-445-1397    gartnek@ccf.org   
Principal Investigator: Carol Langford, MD, MHS         
Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada
Contact: Sandra Messier       smessier@stjoes.ca   
Principal Investigator: Nader Khalidi, MD, FRCPC         
Mount Sinai Hospital, Toronto Recruiting
Toronto, Ontario, Canada, M5L 3L9
Contact: Samyukta Jagadeesh    416-586-8616    sjagadeesh@mtsinai.on.ca   
Principal Investigator: Simon Carette, MD         
Sponsors and Collaborators
Peter Merkel
Office of Rare Diseases (ORD)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Rare Diseases Clinical Research Network
Study Chair: Peter A. Merkel, MD, MPH University of Pennsylvania

Additional Information:
Responsible Party: Peter Merkel, Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00744952     History of Changes
Other Study ID Numbers: VCRC5515
U54AR057319 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

Keywords provided by Peter Merkel, University of Pennsylvania:
Large-vessel vasculitis

Additional relevant MeSH terms:
Takayasu Arteritis
Aortic Arch Syndromes
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases