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Use of Magnetic Resonance and Positron Emission Tomography for Assessing Disease Activity in People With Large-Vessel Vasculitis (Takayasu's Arteritis)

This study is currently recruiting participants.
Verified by Office of Rare Diseases (ORD), September 2008

Sponsored by: Office of Rare Diseases (ORD)
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00744952
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Office of Rare Diseases (ORD):

Primary Outcome Measures:
  • Disease activity [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:   36
Study Start Date:   August 2008

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 72 hours of participants' routine MRI scans. This study will not require any follow-up visits.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.


Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744952

Contacts
Contact: Carol King, MA     617-414-2505     caking@bu.edu    

Locations
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    

Sponsors and Collaborators

Investigators
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    
  More Information


Publications:

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

Keywords provided by Office of Rare Diseases (ORD):
Large-vessel vasculitis  

Study placed in the following topic categories:
Takayasu arteritis
Aortic Diseases
Vasculitis
Skin Diseases
Takayasu Arteritis
Aortic Arch Syndromes
Vascular Diseases
Arteritis

Additional relevant MeSH terms:
Skin Diseases, Vascular
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 24, 2008




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