Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects

Study Overview
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Brief Summary
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The EDEN study will make it possible to evaluate one or more development phases (from design to validation through optimization) of a method or a technique on voluntary subjects, in normal or pathological condition.

Official Title
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Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects

Conditions
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Healthy, Pathology

Intervention / Treatment
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* Device: MRI examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for all subjects : to be over 18 year-old, to be enrolled in a social security plan, to have underwent a pre-inclusion medical examination, to give a written consent. Inclusion Criteria for volunteers with pathology : - person with a pathology characterized by a functional and / or morphological alteration that may have an impact on the data collected (images, physiological signals, ...). Exclusion Criteria for all subjects : any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, … ), subject under a measure of legal protection, Person who refuses to be informed by a doctor in th event of a fortuitus discovery of an abnormality on the MRI examination requiring additionnal examinations or specific treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All subjects will have an MRI examination<br> | Device: MRI examination<br>* All subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality based on standard imaging quality criteria | The image quality will be appreciated visually at least by a radiologist or a researcher. | 6 months after the last inclusion | 
| Signal quality based on standard signal quality criteria | The signal quality will be appreciated visually at least by a radiologist or a researcher. | 6 months after the last inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the Signal to Noise Ratio obtained by the component of the MRI system under development and the reference situation. | ignal to Noise Ratio will be measured in arbitrary units. | 6 months after the last inclusion | 
| Comparison of the Contrast to Noise Ratio obtained by the component of the MRI system under development and the reference situation. | Contrast to Noise Ratio will be measured in arbitrary units. | 6 months after the last inclusion | 
| Comparison of blurring and artefacts obtained by the component of the MRI system under development and the reference situation. | Absence of blurring and artefacts will be assessed by at least one radiologist according to an ordinal scale (1 to 5 ; 1 is the worst score and 5 is the better score). | 6 months after the last inclusion |