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

Not Applicable

Completed

• Conditions: Gout
• Interventions: Procedure: ultrasonography; Procedure: DECT

• Registration Number: NCT03162341
• Lead Sponsor: Lille Catholic University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Study Start: 2017-08-10
• Primary Completion: 2021-11-08
• Study Completion: 2021-11-08
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UltraSonography and DECT	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.
UltraSonography and DECT	ultrasonography	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.

Primary Outcome Measures

Name	Time	Method
Correlation between US and DECT measurement of change in tophus volume	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 Outcome Measures

Name	Time	Method
Correlation between US and DECT measurement of change in tophus volume	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.
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	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.
Correlation between the change of DECT urate score and the number of gout attacks	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.
Change of DECT urate score	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
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	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.

Trial Locations

Locations (3)

Hospital Group of the Catholic Institute; 🇫🇷 Lomme, France

Bichat Hospital; 🇫🇷 Paris, France

Lariboisière Hospital; 🇫🇷 Paris, France