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

March 16, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • ILE DE fRANCE
      • Paris, ILE DE fRANCE, France, 75010
        • Recruiting
        • Reumatology Department Lariboisière Hospital
    • Ile De France
      • Paris, Ile De France, France, 75010
        • Recruiting
        • Radiology Department Lariboisière Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 6 months +/- 1 month of traitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Canon U.S.A., Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2019

Primary Completion (Anticipated)

October 11, 2023

Study Completion (Anticipated)

October 11, 2023

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P180451

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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