MRI Clinical Trial
— OPTI-DTIOfficial title:
Optimisation of Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI) : a Feasibility Study
Verified date | February 2021 |
Source | Lille Catholic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
France | Lille Catholic Hospitals | Lomme |
Lead Sponsor | Collaborator |
---|---|
Lille Catholic University |
France,
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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