Variability of Cerebral MRI Diffusion Parameters by Using a Patented Normalization Process vs no Use

NCT05446922 | Unknown

• 1 other identifier: 2022-A00622-41
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Brain MRI

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (3)

• Coefficients of Variation (%CV) of MD measurement

  Day 1

• Coefficients of Variation (%CV) of AD measurement

  Day 1

• Coefficients of Variation (%CV) of RD measurement

  Day 1

Other Outcomes (3)

• Intraclass Correlation Coefficient (ICC)

  Day 1

• percentage Coefficient of Variation (%CV) of the Neurite Orientation Dispersion and Density Imaging (NODDI) multishell diffusion scalar parameters.

  Day 1

• percentage Coefficient of Variation (%CV) of the resting-state functional MRI (fMRI) parameters.

  Day 1

Study Arms (1)

MRI imaging of 10 healthy volunteers

OTHER

10 healthy volunteers will proceed at an brain MRI imaging

Other: Diffusion MRI

Interventions

Diffusion MRI OTHER

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.

MRI imaging of 10 healthy volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braintale: lead

MeSH Terms

Interventions

Diffusion Tensor Imaging

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• PERLBARG Vincent

  Braintale

  STUDY CHAIR

Central Study Contacts

URIET Dorothée

CONTACT

+33686116089; dorothee.uriet@braintale.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 7, 2022
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share