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NCT00174954 Clinical Trial

Magnetic Resonance Imaging in Subjects With Gouty Tophi

Gout Clinical Trial

Official title:
A Study to Validate Magnetic Resonance Imaging (MRI) in the Quantitative Assessment of Gouty Tophi.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00174954
Other study ID # TMX-01-013
Secondary ID U1111-1113-9856
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated July 22, 2010
Start date March 2002
Est. completion date January 2003

Study information
Verified date July 2010
Source Takeda
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine the reproducibility of Magnetic Resonance Imaging (MRI) in the quantitative assessment of tophus volume.

Description:

This is a multi-center, validation study of MRI in the quantitative assessment of gouty tophi. Subjects with palpable gouty tophi (confirmed by aspiration of the tophus) in select anatomical sites (foot, hand or elbow) will undergo pre- and post contrast MRI on two occasions separated by 5 to 10 days. This study will consist of up to 4 study visits.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date January 2003
Est. primary completion date January 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Subjects with gout and at least one tophi.

Exclusion Criteria:

- Unable to undergo MRI.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• MRI
Subjects underwent MRI to evaluate tophi.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Takeda

References & Publications (1)

Schumacher HR Jr, Becker MA, Edwards NL, Palmer WE, MacDonald PA, Palo W, Joseph-Ridge N. Magnetic resonance imaging in the quantitative assessment of gouty tophi. Int J Clin Pract. 2006 Apr;60(4):408-14. Erratum in: Int J Clin Pract. 2006 May;60(5):630. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of Tophi by MRI - Difference in Volument Between Visits Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in volume between Visit 1 and 2 for the same tophus was pooled across readers. Visit 1 (Day 1) and Visit 2 (Days 6-11) No
Primary Measurement of Tophi by MRI - Difference in Volume Between Readers Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in Reader 2 volume and Reader 1 volume for the same tophus were pooled across visits. Visit 1 (Day 1) and Visit 2 (Days 6-11) No
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