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CompletedNCT04224077OPTI-DTIUpdated Feb 3, 2021

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

An interventional study of Optimisation of DTI sequences in Radiculopathy Lumbar, MRI and Diffusion Tensor Imaging, sponsored by Lille Catholic University. Completed at 1 site in France. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-03.

Sponsored by Lille Catholic University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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)
02

Conditions studied

  • Radiculopathy Lumbar
  • MRI
  • Diffusion Tensor Imaging

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Keywords

  • Radiculopathy Lumbar
  • MRI
  • Diffusion tensor imaging
  • Multiband technique
03

In context

Radiculopathy

488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 376 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

Lille Catholic University is the lead sponsor of 111 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Person without history of lumbar surgery
  • Person who has previously consented

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Intervention

    Healthy volunteers

    Diagnostic Test: Optimisation of DTI sequences

Interventions

  • Diagnostic testOptimisation of DTI sequences

    Optimisation of DTI sequences in the study of lumbar roots by MRI

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0

Secondary outcomes

  1. 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.

    Time frame: Day 0

  2. Concordance of observed agreement measured by Cohen's kappa coefficient

    Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)

    Time frame: Day 0

  3. Concordance of observed agreement measured by Intra-class correlation coefficient

    Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)

    Time frame: Day 0

07

Study locations

1 site
  • Lille Catholic Hospitals
    Lomme, 59462, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04224077
Lead sponsor
Lille Catholic University
Responsible party
Sponsor
First posted
Jan 13, 2020
Start date
Feb 10, 2020
Primary completion
Feb 10, 2020
Completion
Aug 31, 2020
Last update
Feb 3, 2021

Study contacts

Jean-François BUDZIK, MD
principal investigator · GHICL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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