Magnetic Resonance Imaging in Subjects With Gouty Tophi

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

Completed

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Key information

Conditions

Hyperuricemia Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects with gout and at least one tophi.

Exclusion criteria

Unable to undergo MRI.

Treatment and study plan

MRI

Procedure

Subjects underwent MRI to evaluate tophi.

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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Sep 15, 2005
Registry last updated: Jul 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed