Magnetic Resonance Imaging in Subjects With Gouty Tophi

Takeda32 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hyperuricemia Gout

Interventions

MRIPROCEDURE

Subjects underwent MRI to evaluate tophi.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with gout and at least one tophi. Exclusion Criteria: * Unable to undergo MRI.

Outcomes

Primary Outcomes

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.

Time frame: Visit 1 (Day 1) and Visit 2 (Days 6-11)

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.

Time frame: Visit 1 (Day 1) and Visit 2 (Days 6-11)

Data from ClinicalTrials.gov

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