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

Not Applicable

Completed

• Conditions: Radiculopathy Lumbar; Diffusion Tensor Imaging; MRI
• Interventions: Diagnostic Test: Optimisation of DTI sequences

• Registration Number: NCT04224077
• Lead Sponsor: Lille Catholic University

Brief Summary

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.

Detailed Description

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)

Study Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-02-10
• Primary Completion: 2020-02-10
• Study Completion: 2020-08-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Optimisation of DTI sequences	Healthy volunteers

Primary Outcome Measures

Name	Time	Method
Image quality measured as signal-to-noise ratio and contrast-to-noise ratio	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 Outcome Measures

Name	Time	Method
Fraction of anisotropy and apparent diffusion coefficient	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.
Concordance of observed agreement measured by Cohen's kappa coefficient	Day 0	Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)
Concordance of observed agreement measured by Intra-class correlation coefficient	Day 0	Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)

Trial Locations

Locations (1)

Lille Catholic Hospitals; 🇫🇷 Lomme, France