Active, Not Recruiting

NCT Number: NCT03965676

Evolution of Tophus and Erosions of Hands and Feet at DECT

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tophaceous Gout

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radiology Department Lariboisière Hospital, Paris, Île-de-France Region, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dual-Energy Computed Tomography examination

Other

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).

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

Canon U.S.A., Inc.

Registry information

Official study title

Evolution of Tophus and Erosions of Hands and Feet With Urate-lowering Therapy: Prospective Study Using Dual-Energy Computed Tomography

Acronym: TOPHERO-CT

Important dates

Study start: 2019
Primary completion: 2025
Study completion: 2025
First posted: May 29, 2019
Registry last updated: Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting