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CompletedNCT00744952Updated Oct 19, 2018

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

An observational study in Takayasu Arteritis, sponsored by Peter Merkel. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-19.

Sponsored by Peter Merkel · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
26
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Takayasu Arteritis

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Keywords

  • Large-vessel vasculitis
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In context

Takayasu Arteritis

78 studies on the registry are indexed under Takayasu Arteritis; 32 are open to participants now.

This study's enrollment of 26 is below the median of 224 across 41 observational studies indexed under Takayasu Arteritis.

Browse Takayasu Arteritis studies →

Lead sponsor

Peter Merkel is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Unable to comply with study guidelines
  • Unable to safely undergo MRI scanning
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
26 participants (actual)
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What researchers measure

Primary outcomes

  1. Disease activity

    Time frame: Measured throughout the study

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Study locations

5 sites
  • Boston University School of Medicine
    Boston, Massachusetts 02118, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • St. Joseph's Healthcare
    Hamilton, Ontario, Canada
  • Mount Sinai Hospital, Toronto
    Toronto, Ontario M5L 3L9, Canada
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References and documents

Publications

  • 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. PubMed 11792888 ↗
  • 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. PubMed 11318006 ↗
  • 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. PubMed 12853590 ↗
  • 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. PubMed 12115196 ↗
  • 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. PubMed 15248230 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00744952
Lead sponsor
Peter Merkel
Responsible party
Peter Merkel (Professor, University of Pennsylvania) — Sponsor-investigator
First posted
Sep 1, 2008
Start date
Aug 2008
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018
Last update
Oct 19, 2018

Study contacts

Peter A. Merkel, MD, MPH
study chair · University of Pennsylvania

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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