NCT03162341

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2021

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

May 18, 2017

Last Update Submit

April 27, 2026

Conditions

Gout

Keywords

Dual-Energy Computed TomographyUltraSonographyGoutUrate deposition

Outcome Measures

Primary Outcomes (1)

  • Correlation between US and DECT measurement of change in tophus volume

    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 Outcomes (5)

  • Correlation between US and DECT measurement of change in tophus volume

    after 6 months, 12 months and 24 months of treatment

  • Change of 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

    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

    after 6 months, 12 months and 24 months of treatment

  • Correlation between the change of DECT urate score and the number of gout attacks

    after 6 months, 12 months and 24 months of treatment

Study Arms (1)

UltraSonography and DECT

EXPERIMENTAL

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: ultrasonographyProcedure: DECT

Interventions

ultrasonographyPROCEDURE

The tophus volume will be assess using ultrasonography.

UltraSonography and DECT
DECTPROCEDURE

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

Also known as: dual-energy computed tomography
UltraSonography and DECT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy or breastfeeding
  • patient under legal guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Group of the Catholic Institute

Lomme, 59462, France

Location

Bichat Hospital

Paris, 75018, France

Location

Lariboisière Hospital

Paris, 75475, France

Location

Related Publications (1)

  • Pascart T, Richette P, Bousson V, Ottaviani S, Ea HK, Liote F, Latourte A, Bardin T, Ora J, Pacaud A, Vandecandelaere M, Luraschi H, Jauffret C, Laurent V, Boissel M, Norberciak L, Legrand J, Lefevre G, Ducoulombier V, Budzik JF. Time-course of tophus resolution on Dual-energy CT and ultrasound after 24months of a treat-to-target strategy: Results from GOUT-DECTUS study. Joint Bone Spine. 2025 Jul;92(4):105892. doi: 10.1016/j.jbspin.2025.105892. Epub 2025 Mar 24.

    PMID: 40139560RESULT

MeSH Terms

Conditions

Gout

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Tristan Pascart, MD

    Hospital Group of the Catholic Institute of Lille

    STUDY DIRECTOR

  • Sébastien Ottaviani, MD

    Bichat Hospital of Paris

    PRINCIPAL INVESTIGATOR

  • Pascal Richette, MD PhD

    Lariboisiere Hospital of Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 22, 2017

Study Start

August 10, 2017

Primary Completion

November 8, 2021

Study Completion

November 8, 2021

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

FR(3)