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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05065606
Other study ID # APHP180476
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2016
Est. completion date November 30, 2021

Study information

Verified date September 2021
Source Assistance Publique - Hôpitaux de Paris
Contact Valérie BOUSSON, PUPH
Phone +33(0)149959107
Email valerie.bousson@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Dual-energy computed tomography
Dual-energy scanner examinations stored in the PACS (medical imagery) at Lariboisière Hospital are to be analyzed retrospectively and prospectively

Locations

Country Name City State
France Hôpital Bichat - Service de Rhumatologie Paris
France Hôpital Lariboisière - Service d'Imagerie OstéoArticulaire, Viscérale et Vasculaire Paris
France Hôpital Lariboisière - Service de Rhumatologie Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Canon Medical Systems, USA

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Distribution of urate deposits Distribution of urate deposits in soft tissues and bone, and joint erosions and destruction The day of the CT examination
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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