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

NCT ID: NCT03162341

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-10

Study Completion Date

2021-11-08

Brief Summary

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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.

Detailed Description

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Conditions

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Gout

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ultrasonography

Intervention Type PROCEDURE

The tophus volume will be assess using ultrasonography.

DECT

Intervention Type PROCEDURE

The tophus volume will be assess using dual-energy computed tomography (DECT).

Interventions

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ultrasonography

The tophus volume will be assess using ultrasonography.

Intervention Type PROCEDURE

DECT

The tophus volume will be assess using dual-energy computed tomography (DECT).

Intervention Type PROCEDURE

Other Intervention Names

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dual-energy computed tomography

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Horizon Pharma Rheumatology LLC

INDUSTRY

Sponsor Role collaborator

Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tristan Pascart, MD

Role: STUDY_DIRECTOR

Hospital Group of the Catholic Institute of Lille

Sébastien Ottaviani, MD

Role: PRINCIPAL_INVESTIGATOR

Bichat Hospital of Paris

Pascal Richette, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Lariboisiere Hospital of Paris

Locations

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Hospital Group of the Catholic Institute

Lomme, , France

Site Status

Bichat Hospital

Paris, , France

Site Status

Lariboisière Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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RC-P0056

Identifier Type: -

Identifier Source: org_study_id

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