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

MRI Clinical Trial

— OPTI-DTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224077
• Other study ID #: RC-P0060
• Status: Completed
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2021
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diffusion Tensor Imaging
• MRI
• Radiculopathy
• Radiculopathy Lumbar

Intervention

Diagnostic Test:
• Optimisation of DTI sequences
Optimisation of DTI sequences in the study of lumbar roots by MRI

Locations

Country	Name	City	State
France	Lille Catholic Hospitals	Lomme

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Concordance of observed agreement measured by Cohen's kappa coefficient	Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)	Day 0
Secondary	Concordance of observed agreement measured by Intra-class correlation coefficient	Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)	Day 0