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Completed

NCT Number: NCT02738424

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint Etienne

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • <18 years old

Treatment and study plan

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.

Primary outcomes

  1. ADC Score according to the post-processing software used

    Time frame: 1 day

    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.

Secondary outcomes

  1. ADC Score according to the intensity of MRI

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: ADC

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2016
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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