Magnetic Resonance Imaging in Subjects With Gouty Tophi
This study has been completed.
Sponsor:
Takeda Global Research & Development Center, Inc.
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00174954
First received: September 12, 2005
Last updated: July 22, 2010
Last verified: July 2010
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Purpose
The purpose of this study is to determine the reproducibility of Magnetic Resonance Imaging (MRI) in the quantitative assessment of tophus volume.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperuricemia Gout |
Procedure: MRI |
Phase 2 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | A Study to Validate Magnetic Resonance Imaging (MRI) in the Quantitative Assessment of Gouty Tophi. |
Resource links provided by NLM:
Further study details as provided by Takeda Global Research & Development Center, Inc.:
Primary Outcome Measures:
- Measurement of Tophi by MRI - Difference in Volument Between Visits [ Time Frame: Visit 1 (Day 1) and Visit 2 (Days 6-11) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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.
Biospecimen Retention: None Retained
None taken or retained.
| Enrollment: | 32 |
| Study Start Date: | March 2002 |
| Study Completion Date: | January 2003 |
| Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Volumes/measurements of tophi determined by serial MRIs
|
Procedure: MRI
Subjects underwent MRI to evaluate tophi.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects with palpable gouty tophi.
Criteria
Inclusion Criteria:
- Subjects with gout and at least one tophi.
Exclusion Criteria:
- Unable to undergo MRI.
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00174954 History of Changes |
| Other Study ID Numbers: | TMX-01-013, U1111-1113-9856 |
| Study First Received: | September 12, 2005 |
| Results First Received: | March 12, 2009 |
| Last Updated: | July 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Takeda Global Research & Development Center, Inc.:
|
Gout Tophus MRI |
Additional relevant MeSH terms:
|
Gout Hyperuricemia Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013