Skip to main content
OpenTrials
Completed

NCT Number: NCT03162341

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Group of the Catholic Institute, Lomme, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonography

Procedure

The tophus volume will be assess using ultrasonography.

DECT

Procedure

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

Other names: dual-energy computed tomography

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • Horizon Pharma Rheumatology LLC

Registry information

Official study title

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

Acronym: GOUT

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 22, 2017
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.