Evolution of Tophus and Erosions of Hands and Feet at DECT
NCT ID: NCT03965676
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2019-07-24
2025-10-11
Brief Summary
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Study hypothesis
* The dynamics of tophus resolution with urate-lowering therapy is poorly understood.
* It is variable according to the location of the tophus, peri articular / intratendinous, but also probably at the feet / hands, the initial overall volume of the tophus, the initial crystal charge of the tophus. Knowledge of prognostic factors for tophus resolution will help determine the best target for treatment follow-up for each patient.
* Erosions are the consequence of tophus. Tophus resolution could be associated with repair of erosions and stabilization of joint destruction.
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Detailed Description
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Study population
* Adult patients with a tophaceous gout but no urate-lowering treatment or treatment but target not reached (target = uricemia \< 360µmol/L).
* Recruitment of patients during a visit or hospitalization in rheumatology at Lariboisière Hospital.
Calculated size of study population: 50 patients
No control group
Inclusion criteria
* Age greater than or equal to 18 years
* Patient with a tophaceous gout
* Without urate-lowering treatment or with treatment but uricemia not at target
* Having given its free and informed consent to participate in this study
* Affiliated with a social security system
Non-Inclusion criteria
* Pregnant or breastfeeding woman
* Participation in another intervention research or period of exclusion due to a previous research.
* Impossibility to position oneself in ventral position (position for hands/wrists DECT acquisition).
Acts or product added for the research study Dual-Energy Computed Tomography examination at 6 and 12 months +/- 1 month of medical treatment with uricemia \< 360µmol/L (baseline DECT is in the domain of usual care).
For each patient, 3 visits (usual care):
* M0: Inclusion visit
* M6 + /- 1 month: visit, usual care, + DECT for research purpose
* M12 + /- 1 month: visit, usual care, + DECT for research purpose
Research duration:
* Inclusion period: 24 months
* Duration of participation (treatment + follow-up): 12 months + /- 1 month
* Total duration: 37 months
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Adult patients with a tophaceous gout
Adult patients with a tophaceous gout but no urate-lowering treatment or treatment but target not reached (target = uricemia \< 360µmol/L).
Dual-Energy Computed Tomography examination
Dual-Energy Computed Tomography examination at 6 and 12 months +/- 1 month of medical treatment with uricemia \< 360μmol/L (baseline DECT is in the domain of usual care).
Interventions
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Dual-Energy Computed Tomography examination
Dual-Energy Computed Tomography examination at 6 and 12 months +/- 1 month of medical treatment with uricemia \< 360μmol/L (baseline DECT is in the domain of usual care).
Eligibility Criteria
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Inclusion Criteria
* Patient with a tophaceous gout
* Without urate-lowering treatment or with treatment but uricemia not at target
* Having given its free and informed consent to participate in this study
* Affiliated with a social security system
Exclusion Criteria
* Participation in another intervention research or period of exclusion due to a previous research.
* Impossibility to position oneself in ventral position (position for hands/wrists DECT acquisition).
18 Years
100 Years
ALL
No
Sponsors
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Canon U.S.A., Inc.
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Richette Pascal, PhD
Role: PRINCIPAL_INVESTIGATOR
Rheumatology Department Lariboisière Hospital
Locations
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Radiology Department Lariboisière Hospital
Paris, Île-de-France Region, France
Reumatology Department Lariboisière Hospital
Paris, Île-de-France Region, France
Countries
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Other Identifiers
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APHP180451
Identifier Type: -
Identifier Source: org_study_id
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