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

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

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.

Study Overview

• Status: Completed
• Conditions: MRI; Radiculopathy Lumbar; Diffusion Tensor Imaging
• Intervention / Treatment: Diagnostic test: Optimisation of DTI sequences

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lomme, France, 59462
    • Lille Catholic Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Healthy volunteers	Diagnostic test: Optimisation of DTI sequences; Optimisation of DTI sequences in the study of lumbar roots by MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality measured as signal-to-noise ratio and contrast-to-noise ratio	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.	Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Jean-François BUDZIK, MD, GHICL

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2020
• Primary Completion (ACTUAL): February 10, 2020
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (ACTUAL): January 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: MRI; Diffusion tensor imaging; Radiculopathy Lumbar; Multiband technique
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: RC-P0060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No