Magnetic Resonance Imaging in Subjects With Gouty Tophi - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00174954

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 II

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Study to Validate Magnetic Resonance Imaging (MRI) in the Quantitative Assessment of Gouty Tophi.

Resource links provided by NLM:

MedlinePlus related topics: Gout MRI Scans

U.S. FDA Resources

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 ]
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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Chair:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Additional Information:

Uloric Package Insert This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

Publications:

Schumacher HR Jr, Becker MA, Edwards NL, Palmer WE, MacDonald PA, Palo W, Joseph-Ridge N. Magnetic resonance imaging in the quantitative assessment of gouty tophi. Int J Clin Pract. 2006 Apr;60(4):408-14.

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science )
Study ID Numbers:	TMX-01-013
Study First Received:	September 12, 2005
Results First Received:	March 12, 2009
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00174954 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Gout
Tophus
MRI

Study placed in the following topic categories:

Hyperuricemia
Gout

Additional relevant MeSH terms:

Pathologic Processes
Hyperuricemia

ClinicalTrials.gov processed this record on September 02, 2009