Evolution of Tophus and Erosions of Hands and Feet at DECT

NCT03965676 | Active Not Recruiting DMC

• 1 other identifier: APHP180451
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Tophaceous Gout

Keywords

Gout,Dual-energy computed tomography,Tophus,Erosion

Outcome Measures

Primary Outcomes (1)

• the percentage of decrease in crystal volume of the target tophus

  decrease in crystal volume of the target tophus detected using dual-energy CT compared to the volume at baseline

  after 6 months +/- 1 month of traitment

Study Arms (1)

Adult patients with a tophaceous gout

OTHER

Adult patients with a tophaceous gout but no urate-lowering treatment or treatment but target not reached (target = uricemia \< 360µmol/L).

Other: Dual-Energy Computed Tomography examination

Interventions

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).

Adult patients with a tophaceous gout

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding woman
• Impossibility to position oneself in ventral position (position for hands/wrists DECT acquisition).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Canon U.S.A., Inc.: collaborator

Study Sites (2)

Radiology Department Lariboisière Hospital

Paris, Île-de-France Region, 75010, France

Location

Reumatology Department Lariboisière Hospital

Paris, Île-de-France Region, 75010, France

Location

Study Officials

• Richette Pascal, PhD

  Rheumatology Department Lariboisière Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: July 24, 2019
• Primary Completion: October 11, 2025
• Study Completion: October 11, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)