Evolution of Tophus and Erosions of Hands and Feet at DECT (TOPHERO-CT)
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|ClinicalTrials.gov Identifier: NCT03965676|
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : September 24, 2019
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Tophaceous Gout||Other: Dual-Energy Computed Tomography examination||Not Applicable|
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).
- 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
- 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).
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
- Inclusion period: 24 months
- Duration of participation (treatment + follow-up): 12 months + /- 1 month
- Total duration: 37 months
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evolution of Tophus and Erosions of Hands and Feet With Urate-lowering Therapy: Prospective Study Using Dual-Energy Computed Tomography|
|Actual Study Start Date :||July 24, 2019|
|Estimated Primary Completion Date :||December 15, 2019|
|Estimated Study Completion Date :||July 15, 2022|
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).
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).
- the percentage of decrease in crystal volume of the target tophus [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965676
|Contact: Bousson Valérie, PhD||+33149959106 ext +email@example.com|
|Contact: Richette Pascal, PhDfirstname.lastname@example.org|
|Radiology Department Lariboisière Hospital||Recruiting|
|Paris, Ile De France, France, 75010|
|Contact: Bousson Valérie, PhD +33149959106 email@example.com|
|Reumatology Department Lariboisière Hospital||Recruiting|
|Paris, ILE DE fRANCE, France, 75010|
|Contact: Richette Pascal, PhD +33149956290 firstname.lastname@example.org|
|Principal Investigator:||Richette Pascal, PhD||Rheumatology Department Lariboisière Hospital|