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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Pennsylvania
Sponsor:
Collaborators:
Rare Diseases Clinical Research Network
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00744952
First received: August 29, 2008
Last updated: November 22, 2013
Last verified: November 2013

August 29, 2008
November 22, 2013
August 2008
August 2014   (final data collection date for primary outcome measure)
Disease activity [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00744952 on ClinicalTrials.gov Archive Site
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Use of MRI and PET for Assessing Disease Activity in Takayasu's Arteritis
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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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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.

Takayasu Arteritis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States,   Canada
 
NCT00744952
RDCRN 5515, U54AR057319
Yes
Peter Merkel, University of Pennsylvania
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
University of Pennsylvania
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP