Evolution of Tophus and Erosions of Hands and Feet at DECT (TOPHERO-CT)

Assistance Publique - Hôpitaux de Paris

Status

Active, not recruiting

Conditions

Tophaceous Gout

Treatments

Other: Dual-Energy Computed Tomography examination

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03965676

APHP180451

Details and patient eligibility

About

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.

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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).