Evolution of Tophus and Erosions of Hands and Feet at DECT
- Conditions
- Tophaceous Gout
- Interventions
- Other: Dual-Energy Computed Tomography examination
- Registration Number
- NCT03965676
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The main objective is to evaluate the decrease in crystalline volume of the target tophus using Dual-Energy Computed Tomography (DECT), after 6 months +/- 1 month of urate-lowering therapy with target uricemia.
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.
- Detailed Description
Study design The research is a non-randomized prospective bi-centric study in adult patients with tophaceous gout. It aims at studying tophus resolution (main objective), and prognostic factors for tophus resolution (secondary objective), and bone erosions, with Dual-Energy Computed Tomography (DECT) (secondary objective).
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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adult patients with a tophaceous gout Dual-Energy Computed Tomography examination Adult patients with a tophaceous gout but no urate-lowering treatment or treatment but target not reached (target = uricemia \< 360µmol/L).
- Primary Outcome Measures
Name Time Method the percentage of decrease in crystal volume of the target tophus after 6 months +/- 1 month of traitment decrease in crystal volume of the target tophus detected using dual-energy CT compared to the volume at baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Radiology Department Lariboisière Hospital
🇫🇷Paris, Ile de France, France
Reumatology Department Lariboisière Hospital
🇫🇷Paris, ILE DE fRANCE, France