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Active, not recruitingNCT03965676TOPHERO-CTUpdated Sep 12, 2025

Evolution of Tophus and Erosions of Hands and Feet at DECT

An interventional study of Dual-Energy Computed Tomography examination in Tophaceous Gout, sponsored by Assistance Publique - Hôpitaux de Paris. Active, not recruiting at 2 sites in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study 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.
Read the 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
02

Conditions studied

  • Tophaceous Gout

Keywords

  • Gout,Dual-energy computed tomography,Tophus,Erosion
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
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

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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • OtherDual-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).

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: after 6 months +/- 1 month of traitment

07

Study locations

2 sites
  • Radiology Department Lariboisière Hospital
    Paris, Île-de-France Region 75010, France
  • Reumatology Department Lariboisière Hospital
    Paris, Île-de-France Region 75010, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03965676
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Canon U.S.A., Inc.
Responsible party
Sponsor
First posted
May 29, 2019
Start date
Jul 24, 2019
Primary completion
Oct 11, 2025 (estimated)
Completion
Oct 11, 2025 (estimated)
Last update
Sep 12, 2025

Study contacts

Richette Pascal, PhD
principal investigator · Rheumatology Department Lariboisière Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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