Gout, Hyperuricemia
Conditions
Keywords
Gout, Tophus, MRI
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.
Interventions
PROCEDUREMRI
Subjects underwent MRI to evaluate tophi.
Sponsors
Takeda
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with gout and at least one tophi.
Exclusion criteria
* Unable to undergo MRI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Recruitment details
Subjects were enrolled at 6 study centers from 07 March 2002 to 28 January 2003.
Pre-assignment details
Subjects with palpable gouty tophi in select anatomical sites underwent pre- and post-contrast Magnetic Resonance Imaging (MRI)
Participants by arm
| Arm | Count |
|---|---|
| Palpable Gouty Tophi Subjects Volumes/measurements of tophi determined by serial MRI | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | No tophi found in MRI | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Palpable Gouty Tophi Subjects |
|---|---|
| Age Continuous | 61.2 years STANDARD_DEVIATION 15.5 |
| Age, Customized 18 years to 35 years | 1 participants |
| Age, Customized 36 years to 50 years | 9 participants |
| Age, Customized 51 years to 65 years | 7 participants |
| Age, Customized 66 years to 85 years | 13 participants |
| Age, Customized >85 years | 2 participants |
| Race/Ethnicity Black or African American | 9 participants |
| Race/Ethnicity Hispanic | 1 participants |
| Race/Ethnicity White | 22 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 32 |
| serious Total, serious adverse events | 2 / 32 |
Outcome results
Primary
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)
Population: Analysis was performed on the subjects with MRI tophus volume measurements from both readers at the same visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palpable Gouty Tophi Subjects | Measurement of Tophi by MRI - Difference in Volume Between Readers | 0.89 cm³ | Standard Deviation 2.05 |
p-value: 0.02paired t-test
Primary
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)
Population: Analysis was performed on the subjects with MRI tophus volume measurements at both visits from the same reader. Change in tophus size over 10 days was not expected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palpable Gouty Tophi Subjects | Measurement of Tophi by MRI - Difference in Volument Between Visits | Mean Difference | -0.05 centimeters³ (cm³) | Standard Deviation 0.97 |
p-value: 0.785paired t-test