Clinical trial NCT03965676: Evolution of Tophus and Erosions of Hands and Feet at DECT
Official title: Evolution of Tophus and Erosions of Hands and Feet With Urate-lowering Therapy: Prospective Study Using Dual-Energy Computed Tomography
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tophaceous Gout
Keywords: Gout,Dual-energy computed tomography,Tophus,Erosion
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Canon U.S.A., Inc.
First posted: 2019-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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

Exclusion 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).

Primary outcomes:
measure: the percentage of decrease in crystal volume of the target tophus
timeFrame: after 6 months +/- 1 month of traitment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Radiology Department Lariboisière Hospital
state: Ile de France
city: Paris
country: France
facility: Reumatology Department Lariboisière Hospital
state: ILE DE fRANCE
Study officials:
affiliation: Rheumatology Department Lariboisière Hospital
name: Richette Pascal, PhD
role: PRINCIPAL_INVESTIGATOR
References: