Reproductibility of Lumbar Spine ADC Based on Different Post-processing Softwares

Low Back Pain Clinical Trial

— ADC  

Official title:

Reproductibility of Lumbar Spine ADC Based on Different Post-processing Softwares

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738424
• Other study ID #: IRBN642015/CHUSTE
• Status: Completed
• Start date: April 1, 2015
• Est. completion date: November 16, 2015

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Lumbar spine bone marrow is well explored in Magnetic Resonance Imaging (MRI) but some bone marrow diseases are hard to analyze with this method. Furthermore, there is heterogeneity in normal bone marrow, called apparent diffusion coefficient (ADC). Histological and technical factors appear to be the cause, but the possible influence of the employed post-processing software has never yet been evaluated. The purpose of this study is to determine if there is variability in lumbar bone ADC related to the post-processing software.

Description:

Lumbar spine bone marrow is well explored in MRI. Some bone marrow diseases are hard to analyze in conventional MRI, and diffusion-weighted imaging (DWI) could be an additional diagnostic feature. However, according to the literature, there is heterogeneity in normal bone marrow of the quantitative parameter that it provides, called apparent diffusion coefficient (ADC). Histological and technical factors appear to be the cause, but the possible influence of the employed post-processing software has never yet been evaluated. The purpose of this study is to determine if there is variability in lumbar bone ADC related to the post-processing software.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 16, 2015
• Est. primary completion date: November 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive patients undergoing lumbar spine MRI at University Hospital of Saint-Etienne

Exclusion Criteria:

• <18 years old

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Calculate the ADC scores
The MRI will be performed on the two groups of patients in the usual care. The intervention will be based on the ADC scores calculation. The scores will be obtained with three types of post-processing softwares : Siemens, PACS Carestream, Osirix.

Locations

Country	Name	City	State
France	Chu Saint Etienne	St Etienne	Saint Priest En Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADC Score according to the post-processing software used	The ADC Score will be calculated for each patient, with three different post-processing softwares : Siemens, PACS (picture archiving and communication system) Carestream, Osirix. The scores will be compared, because the aim of this study is to demonstrate the variability of this score, according to the post-processing software used.; Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue, and is commonly clinically calculated using Magnetic resonance imaging (MRI) with diffusion weighted imaging (DWI). An ADC of a tissue is expressed in units of mm2/s. There is no unanimity regarding the boundaries of the range of normal diffusion, but ADC values less than 1.0 to 1.1 x 10-3 mm2/s (or 1000-1100 x 10-6 mm2/s) are generally acknowledged in adults as indicating restriction.	1 day
Secondary	ADC Score according to the intensity of MRI	The ADC Score will also be compared to the intensity of the Magnetic resonance imaging (MRI) performed for each patient. Half have received a MRI of 1,5 Tesla and the other hand a 3 Tesla MRI. The variability between these two groups will be compared in the secondary outcome.	1 day