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

• Conditions: Gout

• Registration Number: NCT05065606
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

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 Timeline

• Study Start: 2016-11-30
• Study First Submitted: 2020-11-19
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-22
• Last Update Submitted: 2021-09-22
• Study First Posted: 2021-10-04
• Last Update Posted: 2021-10-04
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distribution of urate deposits	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	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).
Soft tissue tophus description	The day of the CT (computed tomography) examination	Description of soft tissue tophus in terms of location, size, density at high and low energy

Secondary Outcome Measures

Name	Time	Method
Variations in tophaceous burden	The day of the CT examination	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
Reproducibility of a scoring system	The day of the CT examination	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).
Bone mineral density	The day of the CT examination	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)).
Correlation of the descriptive parameters on dual-energy CT with clinical data	The day of the CT examination	to correlate the descriptive parameters on dual-energy CT with clinical data, including disease history and therapeutic management, and serum urate level.
Link between tophus and erosions	The day of the CT examination	To analyze the relationships between bone erosion scores and urate volume (correlation between quantitative values)
Tophus texture	The day of the CT examination	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.

Trial Locations

Locations (3)

Hôpital Lariboisière - Service de Rhumatologie; 🇫🇷 Paris, France

Hôpital Lariboisière - Service d'Imagerie OstéoArticulaire, Viscérale et Vasculaire; 🇫🇷 Paris, France

Hôpital Bichat - Service de Rhumatologie; 🇫🇷 Paris, France