Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit (GOUT)

April 27, 2026 updated by: Lille Catholic University

Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit in Urate Lowering Therapy Initiators

The objective of this research is to evaluate the correlation between DECT and US explorations performed in a routine clinical setting for the measurement of change in tophus size in gout patients after 24 months of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lomme, France, 59462
        • Hospital Group of the Catholic Institute
      • Paris, France, 75018
        • Bichat hospital
      • Paris, France, 75475
        • Lariboisiere Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of gout based on the ACR/EULAR 2015 criteria
  • uricemia ≥6 mg/dL
  • warranted introduction of urate-lowering therapy according to the ACR 2012 or EULAR 2016 criteria
  • signature of the informed consent
  • social insurance affiliation

Exclusion Criteria:

  • pregnancy or breastfeeding
  • patient under legal guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UltraSonography and DECT

UltraSonography and DECT will be used in patient monitoring after 6, 12 and 24 months of treatment in order to evaluate the correlation between the 2 explorations for the measurement in tophus volume change.

Those are interventions that are not part of the standard care of the patients.
Procedure: ultrasonography
The tophus volume will be assess using ultrasonography.
Procedure: DECT
The tophus volume will be assess using dual-energy computed tomography (DECT).
Other Names:
  • dual-energy computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between US and DECT measurement of change in tophus volume
Time Frame: after 24 months of treatment
Spearman rank correlation between the change in tophus volume after 24 months of treatment measured by ultrasonography or by DECT.
after 24 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between US and DECT measurement of change in tophus volume
Time Frame: after 6 months, 12 months and 24 months of treatment
Spearman rank correlation between the change in tophus volume after 6, 12 and 24 months of treatment measured by ultrasonography or by DECT.
after 6 months, 12 months and 24 months of treatment
Change of DECT urate score
Time Frame: after 6 months, 12 months and 24 months of treatment
Change from baseline after 6, 12 and 24 months of treatment in DECT urate score
after 6 months, 12 months and 24 months of treatment
Link between the change of DECT urate score and the persistence of the double contour sign
Time Frame: after 6 months, 12 months and 24 months of treatment

During ultrasonography, a double contour of the articulation can be visible. This outcome will compare the change in the DECT urate score between the patients for who the double contour stay visible and those for who it disapear.

This outcome register if this double contour stay visible.
after 6 months, 12 months and 24 months of treatment
Correlation between the change of DECT urate score and the change in serum uric acid levels
Time Frame: after 6 months, 12 months and 24 months of treatment
The Spearman correlation between the change from baseline of the DECT urate score and the serum uric acid levels will be computed for each time point.
after 6 months, 12 months and 24 months of treatment
Correlation between the change of DECT urate score and the number of gout attacks
Time Frame: after 6 months, 12 months and 24 months of treatment
The Spearman correlation between the change from baseline of the DECT urate score and the number of gout attack will be computed.
after 6 months, 12 months and 24 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Collaborators

Horizon Pharma Rheumatology LLC

Investigators

  • Study Director: Tristan Pascart, MD, Hospital Group of the Catholic Institute of Lille
  • Principal Investigator: Sébastien Ottaviani, MD, Bichat Hospital of Paris
  • Principal Investigator: Pascal Richette, MD PhD, Lariboisiere Hospital of Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2017

Primary Completion (Actual)

November 8, 2021

Study Completion (Actual)

November 8, 2021

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

May 19, 2017

First Posted (Actual)

May 22, 2017

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P0056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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