Evolution of Tophus and Erosions of Hands and Feet at DECT (NCT03965676) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evolution of Tophus and Erosions of Hands and Feet at DECT
France50 participantsStarted 2019-07-24
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the percentage of decrease in crystal volume of the target tophus
Timeframe: after 6 months +/- 1 month of traitment