An observational study in Hyperuricemia and Gout, sponsored by Takeda. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-07-27.
Sponsored by Takeda · Observational
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.
215 studies on the registry are indexed under Hyperuricemia; 40 are open to participants now.
This study's enrollment of 32 is below the median of 200 across 37 observational studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with palpable gouty tophi.
Exclusion Criteria:
Volumes/measurements of tophi determined by serial MRIs
Procedure: MRI
Subjects underwent MRI to evaluate tophi.
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)
Subjects were enrolled at 6 study centers from 07 March 2002 to 28 January 2003.
| Milestone | Palpable Gouty Tophi Subjects |
|---|---|
| Started | 32 |
| Completed | 28 |
| Not completed | 4 |
| Withdrew: Adverse event | 2 |
| Withdrew: No tophi found in mri | 1 |
| Withdrew: Physician decision | 1 |
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.
| centimeters³ (cm³) | Palpable Gouty Tophi Subjects |
|---|---|
| Mean Difference | -0.05 ± 0.97 |
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.
| cm³ | Palpable Gouty Tophi Subjects |
|---|---|
| Measurement of Tophi by MRI - Difference in Volume Between Readers | 0.89 ± 2.05 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Palpable Gouty Tophi Subjects | — | 2/32 (6.3%) | 6/32 (18.8%) |
| Event | Palpable Gouty Tophi Subjects |
|---|---|
| Rate and Rhythm Disorders not elsewhere classified (NEC)Cardiac disorders | 1/32 |
| Renal Failure and ImpairmentRenal and urinary disorders | 1/32 |
| Event | Palpable Gouty Tophi Subjects |
|---|---|
| Gastrointestinal Atonic and Hypomotility Disorders NECGastrointestinal disorders | 1/32 |
| Nausea and Vomiting SymptomsGastrointestinal disorders | 1/32 |
| Febrile DisordersGeneral disorders | 1/32 |
| Muscle Related Signs and Symptoms NECMusculoskeletal and connective tissue disorders | 1/32 |
| Musculoskeletal and Connective Tissue Signs and Symptoms NECMusculoskeletal and connective tissue disorders | 1/32 |
| Nasal Congestion and InflammationsRespiratory, thoracic and mediastinal disorders | 1/32 |
| Age Continuous(years) | Palpable Gouty Tophi Subjects |
|---|---|
| Mean | 61.2 ± 15.5 |
| Age, Customized(participants) | Palpable Gouty Tophi Subjects |
|---|---|
| 18 years to 35 years | 1 |
| 36 years to 50 years | 9 |
| 51 years to 65 years | 7 |
| 66 years to 85 years | 13 |
| >85 years | 2 |
| Sex: Female, Male(Participants) | Palpable Gouty Tophi Subjects |
|---|---|
| Female | 2 |
| Male | 30 |
| Race/Ethnicity(participants) | Palpable Gouty Tophi Subjects |
|---|---|
| White | 22 |
| Black or African American | 9 |
| Hispanic | 1 |
No study locations are listed for this record.
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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