Evolution of Tophus and Erosions of Hands and Feet at DECT | NCT03965676

Studies
Evolution of Tophus and Erosions of Hands and Feet at DECT

NCT03965676

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Active, not recruiting

Last Update Posted

Sep 12, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Tophaceous Gout

Interventions

Dual-Energy Computed Tomography examination

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2019Actual

Primary Completion Date

Oct 11, 2025Estimated

Completion Date

Oct 11, 2025Estimated

First Submitted Date

May 24, 2019

First Submission Date that Met QC Criteria

May 24, 2019

First Posted Date

May 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2025

Last Update Posted Date

Sep 12, 2025Actual

Name	Class
Canon U.S.A., Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richette Pascal, PhD	Rheumatology Department Lariboisière Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radiology Department Lariboisière Hospital		Paris	Île-de-France Region	75010	France
Reumatology Department Lariboisière Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided