Validation and Implementation of 3T MRI Research Protocols

NCT ID: NCT04866940

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2027-05-12

Brief Summary

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The Philips 3T imager installed on the Pavillon Baudot site is an imager dedicated solely to research. It is not located in hospital premises but in INSERM premises for which an authorization for biomedical research has been granted. This equipment is part of the Technical Platform of the UMR 1214 ToNIC whose main objective is the study of the human brain and the main pathologies that affect it.

MRI is an evolving technique, which is used in many research projects. Our technical platform must follow these developments and remain at the cutting edge. One of the essential services of our technical platform is to help set up research protocols and validate acquisition sequences. This development activity is therefore located upstream of research projects involving clinical or fundamental applications. The fact that we can provide our users with a regulatory framework to carry out these development tests for their Research Involving Human Subjects project is a necessity for our research support activity.

This study aims to provide a generic framework to test the feasibility of MRI sequences requested within the framework of protocols, but also to optimize MRI acquisition sequences already in place, to improve image quality and reduce artifacts that can degrade the quality of the images obtained.

In France, there are just over 35 centers with MRI dedicated to research and therefore with a validation protocol allowing them to validate their sequences.

Detailed Description

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This is a prospective monocentric research on major participants (healthy and patients). The optimization of the sequences will be carried out in an incremental way from one control to the other: for each control, several sequences will be carried out for an acquisition time not exceeding one hour of cumulated acquisition (i.e. one hour and a half including the installation and the delays between the sequences). Each sequence lasts between 5 and 20 minutes.

At the end of the examination, the images obtained will be evaluated jointly by an expert neuroradiologist and a research engineer specialized in image analysis according to the criteria mentioned above. This analysis will make it possible to determine the parameters to be modified to improve image quality and to define the acquisition parameters for the next test.

As soon as a sequence is considered optimal, it will be tested on a small number of healthy controls (≈ 5) to ensure interindividual reproducibility of image quality parameters, and then if necessary in the presence of pathology in a few patients (≈ 5).

Conditions

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Magnetic Resonance Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Sequence validation

This research aims to provide a generic framework to test the feasibility of MRI sequences requested as part of protocols, but also to optimize MRI acquisition sequences already in place, to improve image quality and reduce artifacts that can degrade the quality of images obtained.

Group Type EXPERIMENTAL

Sequences test

Intervention Type OTHER

the realization of preliminary acquisitions to validate the feasibility of clinical or cognitive research protocols

Interventions

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Sequences test

the realization of preliminary acquisitions to validate the feasibility of clinical or cognitive research protocols

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female, 18 years of age or older
* Ability to cooperate and remain motionless for up to 1 hour (and lying down for 1.5 hours)
* Ability to understand the instructions given
* Subject who has given written and informed consent prior to any examination required by the research)
* Subject affiliated to a social security system or benefiting from an equivalent system

Exclusion Criteria

* Persons deprived of liberty by judicial or administrative decision
* Psychiatric disorders, disorders of cognitive functions, not allowing the realization of the MRI
* Protected adults (subject to a measure of legal protection) or unable to express their consent
* Subject with Contraindications to MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre PAYOUX, Pr

Role: PRINCIPAL_INVESTIGATOR

Inserm: UMR 1214 ToNIC

Locations

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UMR 1214 ToNIC INSERM

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nathalie VAYSSIERE, PHD

Role: CONTACT

+33562746132

DAGNAC, PHD

Role: CONTACT

+33562746122

Facility Contacts

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PAYOUX Pierre

Role: primary

Other Identifiers

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C20-28

Identifier Type: -

Identifier Source: org_study_id

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