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Clinical Trials in France / NCT03965676
Active, not recruiting Not applicable

Evolution of Tophus and Erosions of Hands and Feet at DECT

NCT03965676 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2019-07-24
Last updated
2025-09-12

Condition(s) studied

Tophaceous Gout

Investigational drug(s) / intervention(s)

Dual-Energy Computed Tomography examination

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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 outcome measure(s)

  • 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

Trial sites (2)

FacilityCityRegionStatus
Radiology Department Lariboisière Hospital Paris Île-de-France Region
Reumatology Department Lariboisière Hospital Paris Île-de-France Region

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03965676 on ClinicalTrials.gov ↗ ← All trials in France