About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
MRI examination
DeviceAll subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.
Treatment groups
Trial outcomes
Primary outcomes
Image quality based on standard imaging quality criteria
The image quality will be appreciated visually at least by a radiologist or a researcher.
Signal quality based on standard signal quality criteria
The signal quality will be appreciated visually at least by a radiologist or a researcher.
Secondary outcomes
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.
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.
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).
Sponsors and contacts
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