GoutGOUTNCT03162341
Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit
A study testing ultrasonography and DECT in people with Gout, run by Lille Catholic University at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gout
- What is being tested?
- ultrasonography and DECT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 10 Aug 2017to 8 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy or breastfeeding
- patient under legal guardianship
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hospital Group of the Catholic Institute
Lomme, 59462
Bichat Hospital
Paris, 75018
Lariboisière Hospital
Paris, 75475
About this study
Official title: Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit in Urate Lowering Therapy Initiators
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.
- Conditions
- Gout
- Being tested
- ultrasonography, DECT
- Keywords
- Dual-Energy Computed Tomography, UltraSonography, Gout, Urate deposition
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyProcedure or surgery
The tophus volume will be assess using ultrasonography.
DECTProcedure or surgery
Also called dual-energy computed tomography
The tophus volume will be assess using dual-energy computed tomography (DECT).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: ultrasonography; Procedure: DECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 24 months of treatment
Secondary outcomes (5)
Correlation between US and DECT measurement of change in tophus volume
Spearman rank correlation between the change in tophus volume after 6, 12 and 24 months of treatment measured by ultrasonography or by DECT.
Measured: after 6 months, 12 months and 24 months of treatment
Change of DECT urate score
Change from baseline after 6, 12 and 24 months of treatment in DECT urate score
Measured: 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
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.
Measured: 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
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.
Measured: after 6 months, 12 months and 24 months of treatment
Correlation between the change of DECT urate score and the number of gout attacks
The Spearman correlation between the change from baseline of the DECT urate score and the number of gout attack will be computed.
Measured: after 6 months, 12 months and 24 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start10 Aug 2017
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon Pharma Rheumatology LLC
- Responsible party
- Sponsor
- Investigators
- Tristan Pascart, MD, Study director, Hospital Group of the Catholic Institute of LilleSébastien Ottaviani, MD, Principal investigator, Bichat Hospital of ParisPascal Richette, MD PhD, Principal investigator, Lariboisiere Hospital of Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162341
- Sponsor's protocol ID
- RC-P0056
- Acronym
- GOUT
- Status last verified
- Apr 2026
- First submitted
- 18 May 2017
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40139560
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit in Urate Lowering Therapy Initiators
- ClinicalTrials.gov ID
- NCT03162341
- Acronym / sponsor ID
- GOUT / RC-P0056
- Conditions
- Gout
- Keywords
- Dual-Energy Computed Tomography, UltraSonography, Gout, Urate deposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Horizon Pharma Rheumatology LLC
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UltraSonography and DECT | Experimental | Procedure: ultrasonography, Procedure: DECTUltraSonography 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- pregnancy or breastfeeding
- patient under legal guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonographyThe tophus volume will be assess using ultrasonography. | Procedure or surgery | UltraSonography and DECT |
| DECTAlso: dual-energy computed tomographyThe tophus volume will be assess using dual-energy computed tomography (DECT). | Procedure or surgery | UltraSonography and DECT |
Primary outcome
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.
5 secondary outcomes
Correlation between US and DECT measurement of change in tophus volume
Time frame: after 6 months, 12 months and 24 months of treatment
Change of DECT urate score
Time frame: 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
Time frame: 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
Time frame: after 6 months, 12 months and 24 months of treatment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Results publication: PubMed 40139560Pascart 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.
- Individual participant dataSharing planned: Undecided
Related trials for Gout
RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan Pascart, MD study director
Hospital Group of the Catholic Institute of Lille
Sébastien Ottaviani, MD principal investigator
Bichat Hospital of Paris
Pascal Richette, MD PhD principal investigator
Lariboisiere Hospital of Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonography and DECT in people with Gout, run by Lille Catholic University at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between US and DECT measurement of change in tophus volume (time frame: after 24 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03162341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.