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

NCT05446922 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-01

No results posted yet for this study

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

Interventions

OTHER

Diffusion MRI

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.

Sponsors & Collaborators

  • Braintale

    lead INDUSTRY

Principal Investigators

  • PERLBARG Vincent · Braintale

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-03-31
Completion
2024-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05446922 on ClinicalTrials.gov