Healthy, Pathology
Conditions
Brief summary
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.
Interventions
DEVICEMRI examination
All subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image quality based on standard imaging quality criteria | 6 months after the last inclusion | The image quality will be appreciated visually at least by a radiologist or a researcher. |
| Signal quality based on standard signal quality criteria | 6 months after the last inclusion | The signal quality will be appreciated visually at least by a radiologist or a researcher. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the Signal to Noise Ratio obtained by the component of the MRI system under development and the reference situation. | 6 months after the last inclusion | 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. | 6 months after the last inclusion | 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. | 6 months after the last inclusion | 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). |
Countries
France
Contacts
CONTACTDamien MANDRY, MD, PhD
CONTACTGabriela HOSSU, PhD
Outcome results
None listed