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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965676
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Canon U.S.A., Inc.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 24, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : July 15, 2022

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965676


Contacts
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Contact: Bousson Valérie, PhD +33149959106 ext +33672213285 valerie.bousson@aphp.fr
Contact: Richette Pascal, PhD +33149956290 pascal.richette@aphp.fr

Locations
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France
Radiology Department Lariboisière Hospital Recruiting
Paris, Ile De France, France, 75010
Contact: Bousson Valérie, PhD    +33149959106    valerie.bousson@aphp.fr   
Reumatology Department Lariboisière Hospital Recruiting
Paris, ILE DE fRANCE, France, 75010
Contact: Richette Pascal, PhD    +33149956290    pascal.richette@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Canon U.S.A., Inc.
Investigators
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Principal Investigator: Richette Pascal, PhD Rheumatology Department Lariboisière Hospital
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03965676    
Other Study ID Numbers: P180451
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: April 2019

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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