Radiculopathy LumbarOPTI-DTINCT04224077
Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI)
A study testing Optimisation of DTI sequences in people with Radiculopathy Lumbar and MRI, run by Lille Catholic University at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiculopathy Lumbar, MRI, Diffusion Tensor Imaging
- What is being tested?
- Optimisation of DTI sequences
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2020to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Person without history of lumbar surgery
- Person who has previously consented
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimisation of Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI) : a Feasibility Study
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)
- Conditions
- Radiculopathy Lumbar, MRI, Diffusion Tensor Imaging
- Being tested
- Optimisation of DTI sequences
- Keywords
- Radiculopathy Lumbar, MRI, Diffusion tensor imaging, Multiband technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimisation of DTI sequencesDiagnostic test
Optimisation of DTI sequences in the study of lumbar roots by MRI
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Healthy volunteers Receives: Diagnostic Test: Optimisation of DTI sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (3)
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.
Measured: Day 0
Concordance of observed agreement measured by Cohen's kappa coefficient
Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)
Measured: Day 0
Concordance of observed agreement measured by Intra-class correlation coefficient
Evaluation of interobserver accordance for multiband acquisitions (optimized DTI)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start10 Feb 2020
- Primary completion10 Feb 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François BUDZIK, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224077
- Sponsor's protocol ID
- RC-P0060
- Acronym
- OPTI-DTI
- Status last verified
- Feb 2021
- First submitted
- 8 Jan 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI) : a Feasibility Study
- ClinicalTrials.gov ID
- NCT04224077
- Acronym / sponsor ID
- OPTI-DTI / RC-P0060
- Conditions
- Radiculopathy Lumbar, MRI, Diffusion Tensor Imaging
- Keywords
- Radiculopathy Lumbar, MRI, Diffusion tensor imaging, Multiband technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Optimisation of DTI sequencesHealthy volunteers |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Person without history of lumbar surgery
- Person who has previously consented
Key exclusion criteria (6 listed)
- MRI contraindications (pace maker, cardiac defibrillator,...)
- Claustrophobia
- Pregnant woman
- Person without social security
- Person with a guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimisation of DTI sequencesOptimisation of DTI sequences in the study of lumbar roots by MRI | Diagnostic test | Intervention |
Primary outcome
Image quality measured as signal-to-noise ratio and contrast-to-noise ratio
Time frame: Day 0
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.
3 secondary outcomes
Fraction of anisotropy and apparent diffusion coefficient
Time frame: Day 0
Concordance of observed agreement measured by Cohen's kappa coefficient
Time frame: Day 0
Concordance of observed agreement measured by Intra-class correlation coefficient
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François BUDZIK, MD principal investigator
GHICL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimisation of DTI sequences in people with Radiculopathy Lumbar and MRI, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality measured as signal-to-noise ratio and contrast-to-noise ratio (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.