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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Calculate the ADC scores

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• France
  • Saint Priest En Jarez
    • St Etienne, Saint Priest En Jarez, France, 42055
      • CHU Saint Etienne

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

The population studied is composed of 100 patients that will performed an MRI in the CHU de Saint-Etienne. They have lumbar pain, and the MRI is indicated off-study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• <18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
3T patients : Calculate the ADC scores; In this group all the patients perform a 3 Tesla RMI. With these data, three methods will be used to calculate the ADC score : Siemens, PACS (picture archiving and communication system) Carestream, Osirix. The ADC scores obtained with these three post-processing softwares will be compared.	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.
1.5T patients : Calculate the ADC scores; In this group all the patients perform a 1,5 Tesla RMI. With these data, three methods will be used to calculate the ADC score : Siemens, PACS Carestream, Osirix. The ADC scores obtained with these three post-processing softwares will be compared.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Claire BOUTET, MD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): November 16, 2015
• Study Completion (Actual): November 16, 2015

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimated): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Low Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRBN642015/CHUSTE

Plan for Individual participant data (IPD)

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