A Study to Validate Magnetic Resonance Imaging (MRI) in the Quantitative Assessment of Gouty Tophi.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperuricemia
- Sponsor
- Takeda
- Enrollment
- 32
- Primary Endpoint
- Measurement of Tophi by MRI - Difference in Volument Between Visits
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Time Frame: 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
Time Frame: 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.