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

NCT ID: NCT00744952

Last Updated: 2018-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Takayasu Arteritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Office of Rare Diseases (ORD)

NIH

Sponsor Role collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Rare Diseases Clinical Research Network

NETWORK

Sponsor Role collaborator

Peter Merkel

OTHER

Sponsor Role lead

Responsible Party

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Peter Merkel

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Peter A. Merkel, MD, MPH

Role: STUDY_CHAIR

University of Pennsylvania

Locations

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Boston University School of Medicine

Boston, Massachusetts, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status

Mount Sinai Hospital, Toronto

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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Numano F. The story of Takayasu arteritis. Rheumatology (Oxford). 2002 Jan;41(1):103-6. doi: 10.1093/rheumatology/41.1.103. No abstract available.

Reference Type BACKGROUND
PMID: 11792888 (View on PubMed)

Stone JH, Hoffman GS, Merkel PA, Min YI, Uhlfelder ML, Hellmann DB, Specks U, Allen NB, Davis JC, Spiera RF, Calabrese LH, Wigley FM, Maiden N, Valente RM, Niles JL, Fye KH, McCune JW, St Clair EW, Luqmani RA; International Network for the Study of the Systemic Vasculitides (INSSYS). A disease-specific activity index for Wegener's granulomatosis: modification of the Birmingham Vasculitis Activity Score. International Network for the Study of the Systemic Vasculitides (INSSYS). Arthritis Rheum. 2001 Apr;44(4):912-20. doi: 10.1002/1529-0131(200104)44:43.0.CO;2-5.

Reference Type BACKGROUND
PMID: 11318006 (View on PubMed)

Weyand CM, Goronzy JJ. Medium- and large-vessel vasculitis. N Engl J Med. 2003 Jul 10;349(2):160-9. doi: 10.1056/NEJMra022694. No abstract available.

Reference Type BACKGROUND
PMID: 12853590 (View on PubMed)

Tso E, Flamm SD, White RD, Schvartzman PR, Mascha E, Hoffman GS. Takayasu arteritis: utility and limitations of magnetic resonance imaging in diagnosis and treatment. Arthritis Rheum. 2002 Jun;46(6):1634-42. doi: 10.1002/art.10251.

Reference Type BACKGROUND
PMID: 12115196 (View on PubMed)

Hoffman GS, Merkel PA, Brasington RD, Lenschow DJ, Liang P. Anti-tumor necrosis factor therapy in patients with difficult to treat Takayasu arteritis. Arthritis Rheum. 2004 Jul;50(7):2296-304. doi: 10.1002/art.20300.

Reference Type BACKGROUND
PMID: 15248230 (View on PubMed)

Related Links

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http://rarediseasesnetwork.org/vcrc/

Vasculitis Clinical Research Consortium

Other Identifiers

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U54AR057319

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VCRC5515

Identifier Type: -

Identifier Source: org_study_id

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