Tophaceous GoutTOPHERO-CTNCT03965676
Evolution of Tophus and Erosions of Hands and Feet at DECT
A study testing Dual-Energy Computed Tomography examination in people with Tophaceous Gout, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tophaceous Gout
- What is being tested?
- Dual-Energy Computed Tomography examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Jul 2019to 11 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Radiology Department Lariboisière Hospital
Paris, Île-de-France Region, 75010
Reumatology Department Lariboisière Hospital
Paris, Île-de-France Region, 75010
About this study
Official title: 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.
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
- Conditions
- Tophaceous Gout
- Being tested
- Dual-Energy Computed Tomography examination
- Keywords
- Gout,Dual-energy computed tomography,Tophus,Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Energy Computed Tomography examinationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Dual-Energy Computed Tomography examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 6 months +/- 1 month of traitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start24 Jul 2019
- Primary completion11 Oct 2025 (estimated)
- Study completion11 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tophaceous GoutStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Canon U.S.A., Inc.
- Responsible party
- Sponsor
- Investigators
- Richette Pascal, PhD, Principal investigator, Rheumatology Department Lariboisière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965676
- Sponsor's protocol ID
- APHP180451
- Acronym
- TOPHERO-CT
- Status last verified
- Apr 2025
- First submitted
- 24 May 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Tophus and Erosions of Hands and Feet With Urate-lowering Therapy: Prospective Study Using Dual-Energy Computed Tomography
- ClinicalTrials.gov ID
- NCT03965676
- Acronym / sponsor ID
- TOPHERO-CT / APHP180451
- Conditions
- Tophaceous Gout
- Keywords
- Gout,Dual-energy computed tomography,Tophus,Erosion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Canon U.S.A., Inc.
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 11 Oct 2025 (estimated)
- Study completion
- 11 Oct 2025 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with a tophaceous gout | Other | Other: Dual-Energy Computed Tomography examinationAdult patients with a tophaceous gout but no urate-lowering treatment or treatment but target not reached (target = uricemia < 360µmol/L). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-Energy Computed Tomography examinationDual-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). | Other | Adult patients with a tophaceous gout |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richette Pascal, PhD principal investigator
Rheumatology Department Lariboisière Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Energy Computed Tomography examination in people with Tophaceous Gout, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of decrease in crystal volume of the target tophus (time frame: after 6 months +/- 1 month of traitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.