Magnetic Resonance Imaging in Subjects With Gouty Tophi

Completed

• Conditions: Hyperuricemia; Gout
• Interventions: Procedure: MRI

• Registration Number: NCT00174954
• Lead Sponsor: Takeda

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2003-01
• Study Completion: 2003-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Results First Submitted: 2009-03-12
• Results First Submitted QC: 2009-05-26
• Results First Posted: 2009-07-16
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-22
• Last Update Posted: 2010-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Subjects with gout and at least one tophi.

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Exclusion Criteria

• Unable to undergo MRI.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	MRI	Volumes/measurements of tophi determined by serial MRIs

Primary Outcome Measures

Name	Time	Method
Measurement of Tophi by MRI - Difference in Volument Between Visits	Visit 1 (Day 1) and Visit 2 (Days 6-11)	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.
Measurement of Tophi by MRI - Difference in Volume Between Readers	Visit 1 (Day 1) and Visit 2 (Days 6-11)	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.