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Magnetic Resonance Imaging in Subjects With Gouty Tophi

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00174954
First received: September 12, 2005
Last updated: July 22, 2010
Last verified: July 2010
  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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174954

Sponsors and Collaborators
Takeda
Investigators
Study Chair: Medical Director Takeda
  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:
Gout
Tophus
MRI

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014