GoutDECTGOUTNCT05065606
Descriptive Analysis of Dual-energy Computed Tomography Exams of Adult Patients With Gout
An observational study of Gout, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
The main objective is to describe urate deposits (especially in terms of distribution and volume) in soft tissues and bone, and joint erosions and destruction, in adult patients with gout. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout
- What is being tested?
- Dual-energy computed tomography
- How many people
- 150 participants
- Where
- 3 sitesFrance
- Study dates
- 30 Nov 2016to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective analysis of dual-energy CT exams performed in routine care in patients with gout according to ACR criteria, patients included between end of year 2016 and end of year 2021 (retrospective and prospective inclusion, retrospective analysis)
Who may be able to join
- Age greater than or equal to 18 years old;
- Patient with a gout according to ACR (American College of Rheumatology) criteria;
- Affiliated with a social security scheme.
- Dual-energy scanner examinations stored in the PACS at Lariboisière Hospital
Who cannot join
- Pregnant or breastfeeding woman.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hôpital Lariboisière - Service d'Imagerie OstéoArticulaire, Viscérale et Vasculaire
Paris, 75010
Valérie BOUSSON, PUPH, +33(0)149959107, valerie.bousson@aphp.fr
Nicolas Benoist, CCA
- Recruiting
Hôpital Lariboisière - Service de Rhumatologie
Paris, 75010
Hang-Korng Ea, PU-PH, hang-korng.ea@aphp.fr
Pascal Richette, PUPH
- Recruiting
Hôpital Bichat - Service de Rhumatologie
Paris, 75018
Sebastien Ottaviani, PH, sebastien.ottaviani@aphp.fr
Philippe Dieudé, PUPH
About this study
Official title: Descriptive Analysis of Soft-tissue Urate Deposits, and Bone and Joint Destruction in Dual-energy Computed Tomography Exams of Adult Patients With Gout
The main objective is to describe urate deposits (especially in terms of distribution and volume) in soft tissues and bone, and joint erosions and destruction, in adult patients with gout.
Read the detailed description
Gout is the result of hyperuricemia, itself a consequence of a disorder of purine metabolism. This hypuricemia can lead to the deposition of sodium urate crystals in the soft tissues. It is the deposition of sodium urate crystals in and near the joints that causes an intense local inflammatory reaction with episodes of acute joint pain, swelling and functional disability. In the long term, uratic concretions in the soft tissues (tophus) occur, the joints are destroyed (uratic arthropathies), the kidneys also (gouty nephropathy).
Dual-energy CT (Computed Tomography) is a relatively recent technique that allows the identification of certain materials through the analysis of the difference in attenuation of the material exposed to two different X-ray spectra. This technique identifies the crystalline component of tophus.
- Conditions
- Gout
- Being tested
- Dual-energy computed tomography
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy computed tomographyDiagnostic test
Dual-energy scanner examinations stored in the PACS (medical imagery) at Lariboisière Hospital are to be analyzed retrospectively and prospectively
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue tophus description
Description of soft tissue tophus in terms of location, size, density at high and low energy
Measured: The day of the CT (computed tomography) examination
Distribution of urate deposits
Distribution of urate deposits in soft tissues and bone, and joint erosions and destruction
Measured: The day of the CT examination
Descriptive analysis of joint erosions and destruction
Descrition of joint erosions and destruction :erosion size (mm) and location (joint), joint destruction (space narrowing, joint collapse, joint ankylosis).
Measured: The day of the CT examination
Secondary outcomes (6)
Correlation of the descriptive parameters on dual-energy CT with clinical data
to correlate the descriptive parameters on dual-energy CT with clinical data, including disease history and therapeutic management, and serum urate level.
Measured: The day of the CT examination
Variations in tophaceous burden
To study the variations in tophaceous burden according to the choice of technical parameters for deposit analysis.The parameters of dual energy analysis (threshold, optional filter to remove noise, gradients of dual-energy) change the quantitative value provided by the manufacturer. This outcome will be the urate volume obtained at different parameters
Measured: The day of the CT examination
Link between tophus and erosions
To analyze the relationships between bone erosion scores and urate volume (correlation between quantitative values)
Measured: The day of the CT examination
Reproducibility of a scoring system
To develop and evaluate the reproducibility of a scoring system for tophaceous load and structural damage using a dual energy CT. We will try to developp a scoring system combining the tophus load (total tophus volume) and the erosion score (total erosion score).
Measured: The day of the CT examination
Bone mineral density
To evaluate the bone mineral density at the distal radius and correlate it with tophaceous load and joint structural damage. A region of interest at the distal radius (one centimeter above the joint space) will be placed using the computer mouse to obtained the bone mineral density (in Hounshield unit, mean bone mineral density within the ROI (Region Of Interest)).
Measured: The day of the CT examination
Tophus texture
To evaluate tophus texture. The texture of the tophus will be approached qualitatively (homogeneous/heterogeneous) and according to its density (Hounsfield unit) and to the percentage of tophus color-coded by the dual energy analyse.
Measured: The day of the CT examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start30 Nov 2016
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Responsible party
- Sponsor
- Investigators
- Valérie BOUSSON, PUPH, Study director, APHP Lariboisière - Imagerie OstéoArticulaire,ViscéraleValérie BOUSSON, PUPH, Principal investigator, APHP Lariboisière - Imagerie OstéoArticulaire,Viscérale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065606
- Sponsor's protocol ID
- APHP180476
- Acronym
- DECTGOUT
- Status last verified
- Sep 2021
- First submitted
- 19 Nov 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Analysis of Soft-tissue Urate Deposits, and Bone and Joint Destruction in Dual-energy Computed Tomography Exams of Adult Patients With Gout
- ClinicalTrials.gov ID
- NCT05065606
- Acronym / sponsor ID
- DECTGOUT / APHP180476
- Conditions
- Gout
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 4 Oct 2021 (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 describe urate deposits (especially in terms of distribution and volume) in soft tissues and bone, and joint erosions and destruction, in adult patients with gout.
Detailed description
Gout is the result of hyperuricemia, itself a consequence of a disorder of purine metabolism. This hypuricemia can lead to the deposition of sodium urate crystals in the soft tissues. It is the deposition of sodium urate crystals in and near the joints that causes an intense local inflammatory reaction with episodes of acute joint pain, swelling and functional disability. In the long term, uratic concretions in the soft tissues (tophus) occur, the joints are destroyed (uratic arthropathies), the kidneys also (gouty nephropathy).
Dual-energy CT (Computed Tomography) is a relatively recent technique that allows the identification of certain materials through the analysis of the difference in attenuation of the material exposed to two different X-ray spectra. This technique identifies the crystalline component of tophus.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective analysis of dual-energy CT exams performed in routine care in patients with gout according to ACR criteria, patients included between end of year 2016 and end of year 2021 (retrospective and prospective inclusion, retrospective analysis)
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 years old;
- Patient with a gout according to ACR (American College of Rheumatology) criteria;
- Affiliated with a social security scheme.
- Dual-energy scanner examinations stored in the PACS at Lariboisière Hospital
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding woman.
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 tomographyDual-energy scanner examinations stored in the PACS (medical imagery) at Lariboisière Hospital are to be analyzed retrospectively and prospectively | Diagnostic test | – |
Primary outcome
Soft tissue tophus description
Time frame: The day of the CT (computed tomography) examination
Description of soft tissue tophus in terms of location, size, density at high and low energy
Distribution of urate deposits
Time frame: The day of the CT examination
Distribution of urate deposits in soft tissues and bone, and joint erosions and destruction
Descriptive analysis of joint erosions and destruction
Time frame: The day of the CT examination
Descrition of joint erosions and destruction :erosion size (mm) and location (joint), joint destruction (space narrowing, joint collapse, joint ankylosis).
6 secondary outcomes
Correlation of the descriptive parameters on dual-energy CT with clinical data
Time frame: The day of the CT examination
Variations in tophaceous burden
Time frame: The day of the CT examination
Link between tophus and erosions
Time frame: The day of the CT examination
Reproducibility of a scoring system
Time frame: The day of the CT examination
Bone mineral density
Time frame: The day of the CT examination
Tophus texture
Time frame: The day of the CT examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- 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.
Valérie BOUSSON, PUPH study director
APHP Lariboisière - Imagerie OstéoArticulaire,Viscérale
Valérie BOUSSON, PUPH principal investigator
APHP Lariboisière - Imagerie OstéoArticulaire,Viscérale
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gout, run by Assistance Publique - Hôpitaux de Paris at 3 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valérie BOUSSON, PUPH (+33(0)149959107, valerie.bousson@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue tophus description (time frame: The day of the CT (computed tomography) examination). The study lists 3 primary outcomes in all. 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 4 Oct 2021.