Descriptive Analysis of Dual-energy Computed Tomography Exams of Adult Patients With Gout (DECTGOUT)

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.

Study Overview

• Status: Recruiting
• Conditions: Gout
• Intervention / Treatment: Diagnostic test: Dual-energy computed tomography

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Valérie BOUSSON, PUPH; Phone Number: +33(0)149959107; Email: valerie.bousson@aphp.fr
• Study Contact Backup: Name: Valérie BOUSSON, PUPH; Phone Number: +33(0)149959106; Email: valerie.bousson@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Hôpital Lariboisière - Service d'Imagerie OstéoArticulaire, Viscérale et Vasculaire
    • Contact: Valérie BOUSSON, PUPH; Phone Number: +33(0)149959107; Email: valerie.bousson@aphp.fr
    • Sub-Investigator: Nicolas Benoist, CCA
    • Sub-Investigator: Grégoire Attane, CCA
    • Principal Investigator: Valérie Bousson, PUPH
  • Paris, France, 75010
    • Recruiting
    • Hôpital Lariboisière - Service de Rhumatologie
    • Contact: Hang-Korng Ea, PU-PH; Email: hang-korng.ea@aphp.fr
    • Sub-Investigator: Pascal Richette, PUPH
    • Sub-Investigator: Thomas Bardin, PUPH
    • Sub-Investigator: Frederic Lioté, PUPH
    • Sub-Investigator: Aline Frazier, PA
    • Sub-Investigator: Augustin Latourte, MCUPH
    • Sub-Investigator: Jérémy Ora, PA
    • Principal Investigator: Hang-Korng Ea, PUPH
  • Paris, France, 75018
    • Recruiting
    • Hôpital Bichat - Service de Rhumatologie
    • Contact: Sebastien Ottaviani, PH; Email: sebastien.ottaviani@aphp.fr
    • Sub-Investigator: Philippe Dieudé, PUPH
    • Principal Investigator: Sebastien Ottaviani, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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)

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant or breastfeeding woman.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue tophus description	Description of soft tissue tophus in terms of location, size, density at high and low energy	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	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).	The day of the CT examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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)	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).	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)).	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.	The day of the CT examination

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Canon Medical Systems, USA
• Investigators: Study Director: Valérie BOUSSON, PUPH, APHP Lariboisière - Imagerie OstéoArticulaire,Viscérale; Principal Investigator: Valérie BOUSSON, PUPH, APHP Lariboisière - Imagerie OstéoArticulaire,Viscérale

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2016
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout
• Other Study ID Numbers: APHP180476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No