NCT03965676

Evolution of Tophus and Erosions of Hands and Feet at DECT

Evolution of Tophus and Erosions of Hands and Feet With Urate-lowering Therapy: Prospective Study Using Dual-Energy Computed Tomography

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tophaceous Gout

Interventions

Type	Name	Description
OTHER	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).

Timeline

• Start date: 2019-07-24
• Primary completion: 2025-10-11
• Completion: 2025-10-11
• First posted: 2019-05-29
• Last updated: 2025-09-12

Locations

2 sites across 1 country: France