TOPHERO-CT: Evolution of Tophus and Erosions of Hands and Feet at DECT

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03965676
• Collaborator: Canon U.S.A., Inc. (Industry)
• Enrollment: 50
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 48.7
• Patients Per Site: 25
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tophaceous Gout	Other: Dual-Energy Computed Tomography examination	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evolution of Tophus and Erosions of Hands and Feet With Urate-lowering Therapy: Prospective Study Using Dual-Energy Computed Tomography
• Actual Study Start Date: Jul 24, 2019
• Anticipated Primary Completion Date: Jul 15, 2022
• Anticipated Study Completion Date: Aug 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Adult patients with a tophaceous gout 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; 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).

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiology Department Lariboisière Hospital	Paris	Ile De France	France	75010
2	Reumatology Department Lariboisière Hospital	Paris	ILE DE fRANCE	France	75010

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Richette Pascal, PhD, Rheumatology Department Lariboisière Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT03965676
• Other Study ID Numbers: P180451
• First Posted: May 29, 2019
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Gout,Dual-energy computed tomography,Tophus,Erosion

Study Results

No Results Posted as of Feb 22, 2022