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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03162341

Acronym

GOUT

Enrollment

Registered

2017-05-22

Start date

2017-08-10

Completion date

2021-11-08

Last updated

2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Keywords

Dual-Energy Computed Tomography, UltraSonography, Gout, Urate deposition

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.

Interventions

PROCEDUREultrasonography

The tophus volume will be assess using ultrasonography.

PROCEDUREDECT

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026