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NCT Number: NCT04224077

Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI)

Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach that provides morphological information about the microstructures of the nerve roots. DTI is a widely used neuroimaging technique and is a current topic of research in the field of peripheral nerve imaging. The aim of this work is therefore to improve DTI sequences by specifically evaluating the contribution of the multiband technique in healthy volunteers.

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Key information

Conditions

Radiculopathy Lumbar Diffusion Tensor Imaging MRI

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lille Catholic Hospitals

Lomme, 59462, France

About this study

For every healthy volunteer will be acquired:

  • a morphological sequence
  • a reference diffusion tensor sequence covering three lumbar stages (reference DTI),
  • a diffusion tensor sequence acquired in multiband technique, covering three lumbar stages (optimized DTI),
  • a diffusion tensor sequence acquired in a multiband technique, covering a lumbar stage, of higher spatial resolution (centred DTI)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Person without history of lumbar surgery
  • Person who has previously consented

Exclusion criteria

  • MRI contraindications (pace maker, cardiac defibrillator,...)
  • Claustrophobia
  • Pregnant woman
  • Person without social security
  • Person with a guardianship
  • Person carrying metallic surgical material (spine, pelvis, abdomen)

Treatment and study plan

Optimisation of DTI sequences

Diagnostic Test

Optimisation of DTI sequences in the study of lumbar roots by MRI

Primary outcomes

  1. Image quality measured as signal-to-noise ratio and contrast-to-noise ratio

    Time frame: Day 0

    Comparison of the image quality between DTI optimized and DTI of reference. The signal-to-noise ratio is a measure that compares the level of a desired signal to the level of background noise. Mathematically, the signal-to-noise ratio is the quotient of the (mean) signal intensity measured in a region of interest and the standard deviation of the signal intensity in a region outside the anatomy of the object being imaged.

    The contrast-to-noise ratio is a measure of image quality based on a contrast rather than the raw signal.

Secondary outcomes

  1. Fraction of anisotropy and apparent diffusion coefficient

    Time frame: Day 0

    Comparison of fraction of anisotropy, and apparent diffusion coefficient between DTI optimized and DTI of reference.

    The measurement of fraction of anisotropy, and apparent diffusion coefficient provides robust values for quantifying the degree of microstructural abnormalities of nerves.

  2. Concordance of observed agreement measured by Cohen's kappa coefficient

    Time frame: Day 0

    Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)

  3. Concordance of observed agreement measured by Intra-class correlation coefficient

    Time frame: Day 0

    Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

Optimisation of Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI) : a Feasibility Study

Acronym: OPTI-DTI

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2020
Registry last updated
Feb 3, 2021

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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