NCT02738424|Completed
Reproductibility of Lumbar Spine ADC Based on Different Post-processing Softwares
ADC
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ADC
Sponsor study identifier
observational
98
1 country
1
Study Start
April 1, 2015
Actual (reported)Primary Completion
November 16, 2015
Actual (reported)Study Completion
November 16, 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 16, 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2015
Actual (reported)November 16, 2015
Actual (reported)November 16, 2015
Actual (reported)April 11, 2016
Actual (reported)April 14, 2016
Actual (reported)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
ADC Score according to the intensity of MRI
1 day
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.
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.
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.
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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.
Chu Saint Etienne
Saint-Etienne, Saint Priest En Jarez, 42055, France
Claire BOUTET, MD
Centre Hospitalier Universitaire de Saint Etienne
98 participants (actual enrollment reported by the registry).
First Submitted
April 11, 2016
First Posted
April 14, 2016
Study Start
April 1, 2015
Actual (reported)Are Acceptance and Commitment Related to Treatment Response in Chronic Low Back Pain
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Primary Completion
November 16, 2015
Actual (reported)Study Completion
November 16, 2015
Actual (reported)Last Updated
July 20, 2023
Record last verified: 2023-07
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