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Magnetic Resonance Imaging in Subjects With Gouty Tophi

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ClinicalTrials.gov Identifier: NCT00174954
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : July 16, 2009
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Takeda

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

Condition or disease Intervention/treatment
Hyperuricemia Gout Procedure: MRI

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.

Study Type : Observational
Actual Enrollment : 32 participants
Time Perspective: Prospective
Official Title: A Study to Validate Magnetic Resonance Imaging (MRI) in the Quantitative Assessment of Gouty Tophi.
Study Start Date : March 2002
Actual Primary Completion Date : January 2003
Actual Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort Intervention/treatment
1
Volumes/measurements of tophi determined by serial MRIs
Procedure: MRI
Subjects underwent MRI to evaluate tophi.




Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   None Retained
None taken or retained.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174954


Sponsors and Collaborators
Takeda
Investigators
Study Chair: Medical Director Takeda

Additional Information:
Publications of Results:
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 ( Registry Identifier: WHO )
First Posted: September 15, 2005    Key Record Dates
Results First Posted: July 16, 2009
Last Update Posted: July 27, 2010
Last Verified: July 2010

Keywords provided by Takeda:
Gout
Tophus
MRI

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes