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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05218460
Other study ID # 2021-A00243-38
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 23, 2022
Est. completion date May 23, 2027

Study information

Verified date September 2022
Source Central Hospital, Nancy, France
Contact Damien MANDRY, MD, PhD
Phone +33383154202
Email d.mandry@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 720
Est. completion date May 23, 2027
Est. primary completion date May 23, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHRU de Nancy Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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