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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04224077
Other study ID # RC-P0060
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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