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

Takayasu Arteritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744952
• Other study ID #: VCRC5515
• Secondary ID: U54AR057319
• Status: Completed
• Start date: August 2008
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Takayasu Arteritis

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	Mount Sinai Hospital, Toronto	Toronto	Ontario
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Peter Merkel	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Rare Diseases (ORD), Rare Diseases Clinical Research Network

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

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. — View Citation

Numano F. The story of Takayasu arteritis. Rheumatology (Oxford). 2002 Jan;41(1):103-6. — View Citation

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. — View Citation

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. — View Citation

Weyand CM, Goronzy JJ. Medium- and large-vessel vasculitis. N Engl J Med. 2003 Jul 10;349(2):160-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity		Measured throughout the study

External Links

•   Rare Diseases Clinical Research Network
•   Vasculitis Clinical Research Consortium