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

Healthy Clinical Trial

— EDEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218460
• Other study ID #: 2021-A00243-38
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Healthy
• Pathology

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