Evolution of Tophus and Erosions of Hands and Feet at DECT

Tophaceous Gout Clinical Trial

— TOPHERO-CT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03965676
• Other study ID #: P180451
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2019
• Est. completion date: October 11, 2023

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Bousson Valérie, PhD
• Phone: +33149959106
• Email: valerie.bousson[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 11, 2023
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Tophaceous Gout

Intervention

Other:
• 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).

Locations

Country	Name	City	State
France	Radiology Department Lariboisière Hospital	Paris	Ile De France
France	Reumatology Department Lariboisière Hospital	Paris	ILE DE fRANCE

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Canon U.S.A., Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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