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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • MRI examination

    Device

    All subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.

Treatment groups

720 Participants
are divided into 1 treatment group
Group A: All subjects will have an MRI examinationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Image quality based on standard imaging quality criteria

The image quality will be appreciated visually at least by a radiologist or a researcher.

Time frame
6 months after the last inclusion
2

Signal quality based on standard signal quality criteria

The signal quality will be appreciated visually at least by a radiologist or a researcher.

Time frame
6 months after the last inclusion

Secondary outcomes

1

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.

Time frame
6 months after the last inclusion
2

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.

Time frame
6 months after the last inclusion
3

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).

Time frame
6 months after the last inclusion

Other outcomes

Sponsors and contacts

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