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

Primary Purpose

Radiculopathy Lumbar, MRI, Diffusion Tensor Imaging

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Optimisation of DTI sequences
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Radiculopathy Lumbar focused on measuring Radiculopathy Lumbar, MRI, Diffusion tensor imaging, Multiband technique

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Lille Catholic Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Healthy volunteers

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Concordance of observed agreement measured by Cohen's kappa coefficient
Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)
Concordance of observed agreement measured by Intra-class correlation coefficient
Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)

Full Information

First Posted
January 8, 2020
Last Updated
February 2, 2021
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT04224077
Brief Title
Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI)
Acronym
OPTI-DTI
Official Title
Optimisation of Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI) : a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy Lumbar, MRI, Diffusion Tensor Imaging
Keywords
Radiculopathy Lumbar, MRI, Diffusion tensor imaging, Multiband technique

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Healthy volunteers
Intervention Type
Diagnostic Test
Intervention Name(s)
Optimisation of DTI sequences
Intervention Description
Optimisation of DTI sequences in the study of lumbar roots by MRI
Primary Outcome Measure Information:
Title
Image quality measured as signal-to-noise ratio and contrast-to-noise ratio
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Fraction of anisotropy and apparent diffusion coefficient
Description
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.
Time Frame
Day 0
Title
Concordance of observed agreement measured by Cohen's kappa coefficient
Description
Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)
Time Frame
Day 0
Title
Concordance of observed agreement measured by Intra-class correlation coefficient
Description
Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François BUDZIK, MD
Organizational Affiliation
GHICL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lille Catholic Hospitals
City
Lomme
ZIP/Postal Code
59462
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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