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

NCT02738424 | Completed

• 1 other identifier: IRBN642015/CHUSTE
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

Low Back Pain; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ADC Score according to the intensity of MRI

  1 day

Study Arms (2)

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

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

Interventions

Calculate the ADC scores OTHER

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; 3T patients : Calculate the ADC scores

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \<18 years old

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, Saint Priest En Jarez, 42055, France

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claire BOUTET, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: April 1, 2015
• Primary Completion: November 16, 2015
• Study Completion: November 16, 2015
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)