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

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Brief Title

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

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

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.
    

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


Primary Outcome

Disease activity


Condition

Takayasu Arteritis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

26

Start Date

August 2008

Completion Date

September 30, 2018

Primary Completion Date

September 30, 2018

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter A. Merkel, MD, MPH, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00744952

Organization ID

VCRC5515

Secondary IDs

U54AR057319

Responsible Party

Sponsor-Investigator

Study Sponsor

Peter Merkel

Collaborators

 Office of Rare Diseases (ORD)

Study Sponsor

Peter A. Merkel, MD, MPH, Study Chair, University of Pennsylvania


Verification Date

October 2018