Brain MRICALINCT05446922
Variability of Cerebral MRI Diffusion Parameters by Using a Patented Normalization Process vs no Use
A study testing Diffusion MRI in people with Brain MRI, run by Braintale.
Trial summary
BrainTale has developed a standardization approach based on averaging measurements in predefined brain regions of interest and use of reference data acquired from healthy volunteers under conditions (MRI machine, acquisition protocol) identical to those used for the examination of the patient. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain MRI
- What is being tested?
- Diffusion MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to May 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18 up to 80 years old
- Covered by a healthcare insurance
- Agreeing to be informed about any incidental finding discovered on brain MRI
- Written informed consent form signed
Who cannot join
- History of brain pathology, cognitive or psychiatric disorder
- Any contraindication * for undergoing brain MRI
- Subject refusing to participate or having expressed refusal to data collection/processing or unable to give his/her agreement to participate
- Vulnerable subject (i.e. pregnant or breast-feeding woman, child, subject under curatorship or deprived of liberty)
- contraindications to MRI include: pacemaker, neural stimulator, intraocular or intracerebral device, cochlear implant, MR-incompatible prosthetic heart valves, any implant with metallic, ferromagnetic or electrically conductive parts, any metal in the body which cannot be removed, claustrophobia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: National, Multicentre, Prospective, Interventional Study of the Variability of Cerebral MRI Diffusion Parameters by Using a Patented Normalization Process Versus no Use of Normalization Process
BrainTale has developed a standardization approach based on averaging measurements in predefined brain regions of interest and use of reference data acquired from healthy volunteers under conditions (MRI machine, acquisition protocol) identical to those used for the examination of the patient. The present study is intended to support the normalization step on healthy volunteers in clinical centres that will be equipped with the BrainTale medical device software dedicated to clinical routine practice and to assess, through a multicentre study, the impact of this normalization step on the variability of the MRI diffusion parameters. The data collected will support characterization and modelisation of the variability to explore further biais corrections methods. The study will be conducted by neuroradiologists of the neuroradiology departments of five clinical centres in France.
Read the detailed description
Advances in medical imaging have made it possible, from the 1990s, to be able to visualize structural microlesions of the brain thanks to post-processing of the Magnetic Resonance Imaging (MRI) data acquired by the sequence using the diffusion tensor. Mathematical models such as the diffusion tensor have made it possible to quantify in each of the volumetric units of the brain (voxels) measurements correlated to the microstructure of neuronal axons such as the Fractional Anisotropy (FA), the Mean Diffusivity (MD), the Radial Diffusivity (RD) or the Axial Diffusivity (AD). These measurements thus make it possible to quantify the microstructural alterations.
However, the use of Diffusion Tensor Imaging (DTI) technology has limitations and currently, there is no "gold-standard" to validate diffusion measurements, which are currently dependent on acquisition protocols, post-processing software and observers.
To make these diffusion parameters usable in a clinical context, BrainTale has developed a standardization approach based on averaging measurements in predefined brain regions of interest and use of reference data acquired from healthy volunteers under conditions (MRI machine, acquisition protocol) identical to those used for the examination of the patient. This process requires the acquisition of 10 healthy volunteers to calibrate a new MRI protocol, which greatly limits access to the technology in clinical routine and limits the potential technological evolutions of the acquisition.
The study aims to assess the impact of a patented normalization process on the interindividual variability of Fractional Anisotropy (FA) measurements derived from cerebral Diffusion Tensor Imaging (DTI) acquisitions.
A total of 60 healthy volunteers will be included. One or two acquisition will be performed during a single on-site visit in order to collect diffusion parameters outcome data for further analyses (with or without normalization process).
After each acquisition and before inclusion of the following healthy volunteer, anonymised subject's data will be transferred to BrainTale on a secured web platform. BrainTale will be in charge of the Quality Control (QC) of the acquired data and will attribute a QC-passed or QC-failed.
- Conditions
- Brain MRI
- Being tested
- Diffusion MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion MRIOther
All procedures will be performed during a single visit. Subjects will be invited to lie on the scanning bed that will be moved head first into the scanner such as the head lie under the scanner magnets. Hearing protection will be provided to each subject to muffle the noise produced by the MRI scanner. Subjects will also be provided with pillows and blankets to keep them comfortable. They will also be given a call button that they can push to stop the procedure at any time. MRI acquisition will be performed on 1.5T or 3.0T MRI scanners depending on centre's equipment. Acquisition protocol will include the following sequences with the best parameters chosen by local radiologist and technical BrainTale team.
| Study group | Role | What they receive |
|---|---|---|
| MRI imaging of 10 healthy volunteers | Other | 10 healthy volunteers will proceed at an brain MRI imaging Receives: Other: Diffusion MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficients of Variation (%CV) of FA measurement
Percentage Coefficients of Variation (%CV) of FA measurements obtained from QC-passed DTI sequences before and after application of the normalization process.
Measured: Day 1
Secondary outcomes (3)
Coefficients of Variation (%CV) of MD measurement
Percentage Coefficients of Variation (%CV) of MD measurements obtained from QC-passed DTI sequences before and after application of the normalization process.
Measured: Day 1
Coefficients of Variation (%CV) of AD measurement
Percentage Coefficients of Variation (%CV) of AD measurements obtained from QC-passed DTI sequences before and after application of the normalization process.
Measured: Day 1
Coefficients of Variation (%CV) of RD measurement
Percentage Coefficients of Variation (%CV) of RD measurements obtained from QC-passed DTI sequences before and after application of the normalization process.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study startSep 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MRIStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Braintale
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PERLBARG Vincent, Study chair, Braintale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446922
- Sponsor's protocol ID
- 2022-A00622-41
- Acronym
- CALI
- Status last verified
- Jul 2023
- First submitted
- 15 Jun 2022
- Last updated
- 1 Aug 2023
- Results posted
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicentre, Prospective, Interventional Study of the Variability of Cerebral MRI Diffusion Parameters by Using a Patented Normalization Process Versus no Use of Normalization Process
- ClinicalTrials.gov ID
- NCT05446922
- Acronym / sponsor ID
- CALI / 2022-A00622-41
- Conditions
- Brain MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BraintaleIndustry (pharma, biotech, devices)
- Study start
- Sep 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 7 Jul 2022 (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.
BrainTale has developed a standardization approach based on averaging measurements in predefined brain regions of interest and use of reference data acquired from healthy volunteers under conditions (MRI machine, acquisition protocol) identical to those used for the examination of the patient. The present study is intended to support the normalization step on healthy volunteers in clinical centres that will be equipped with the BrainTale medical device software dedicated to clinical routine practice and to assess, through a multicentre study, the impact of this normalization step on the variability of the MRI diffusion parameters. The data collected will support characterization and modelisation of the variability to explore further biais corrections methods. The study will be conducted by neuroradiologists of the neuroradiology departments of five clinical centres in France.
Detailed description
Advances in medical imaging have made it possible, from the 1990s, to be able to visualize structural microlesions of the brain thanks to post-processing of the Magnetic Resonance Imaging (MRI) data acquired by the sequence using the diffusion tensor. Mathematical models such as the diffusion tensor have made it possible to quantify in each of the volumetric units of the brain (voxels) measurements correlated to the microstructure of neuronal axons such as the Fractional Anisotropy (FA), the Mean Diffusivity (MD), the Radial Diffusivity (RD) or the Axial Diffusivity (AD). These measurements thus make it possible to quantify the microstructural alterations.
However, the use of Diffusion Tensor Imaging (DTI) technology has limitations and currently, there is no "gold-standard" to validate diffusion measurements, which are currently dependent on acquisition protocols, post-processing software and observers.
To make these diffusion parameters usable in a clinical context, BrainTale has developed a standardization approach based on averaging measurements in predefined brain regions of interest and use of reference data acquired from healthy volunteers under conditions (MRI machine, acquisition protocol) identical to those used for the examination of the patient. This process requires the acquisition of 10 healthy volunteers to calibrate a new MRI protocol, which greatly limits access to the technology in clinical routine and limits the potential technological evolutions of the acquisition.
The study aims to assess the impact of a patented normalization process on the interindividual variability of Fractional Anisotropy (FA) measurements derived from cerebral Diffusion Tensor Imaging (DTI) acquisitions.
A total of 60 healthy volunteers will be included. One or two acquisition will be performed during a single on-site visit in order to collect diffusion parameters outcome data for further analyses (with or without normalization process).
After each acquisition and before inclusion of the following healthy volunteer, anonymised subject's data will be transferred to BrainTale on a secured web platform. BrainTale will be in charge of the Quality Control (QC) of the acquired data and will attribute a QC-passed or QC-failed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI imaging of 10 healthy volunteers | Other | Other: Diffusion MRI10 healthy volunteers will proceed at an brain MRI imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 up to 80 years old
- Covered by a healthcare insurance
- Agreeing to be informed about any incidental finding discovered on brain MRI
- Written informed consent form signed
Key exclusion criteria (5 listed)
- History of brain pathology, cognitive or psychiatric disorder
- Any contraindication * for undergoing brain MRI
- Subject refusing to participate or having expressed refusal to data collection/processing or unable to give his/her agreement to participate
- Vulnerable subject (i.e. pregnant or breast-feeding woman, child, subject under curatorship or deprived of liberty)
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 |
|---|---|---|
| Diffusion MRIAll procedures will be performed during a single visit. Subjects will be invited to lie on the scanning bed that will be moved head first into the scanner such as the head lie under the scanner magnets. Hearing protection will be provided to each subject to muffle the noise produced by the MRI scanner. Subjects will also be provided with pillows and blankets to keep them comfortable. They will also be given a call button that they can push to stop the procedure at any time. MRI acquisition will be performed on 1.5T or 3.0T MRI scanners depending on centre's equipment. Acquisition protocol will include the following sequences with the best parameters chosen by local radiologist and technical BrainTale team. | Other | MRI imaging of 10 healthy volunteers |
Primary outcome
Coefficients of Variation (%CV) of FA measurement
Time frame: Day 1
Percentage Coefficients of Variation (%CV) of FA measurements obtained from QC-passed DTI sequences before and after application of the normalization process.
3 secondary outcomes
Coefficients of Variation (%CV) of MD measurement
Time frame: Day 1
Coefficients of Variation (%CV) of AD measurement
Time frame: Day 1
Coefficients of Variation (%CV) of RD measurement
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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.
PERLBARG Vincent study chair
Braintale
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion MRI in people with Brain MRI, run by Braintale.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact URIET Dorothée (+33686116089, dorothee.uriet@braintale.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficients of Variation (%CV) of FA measurement (time frame: Day 1). 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 1 Aug 2023.