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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Pathology
• Intervention / Treatment: Device: MRI examination

• Study Type: Interventional
• Enrollment (Anticipated): 720
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriela HOSSU, PhD; Phone Number: +33383155096; Email: g.hossu@chru-nancy.fr
• Study Contact Backup: Name: Damien MANDRY, MD, PhD; Phone Number: +33383154202; Email: d.mandry@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • CHRU de Nancy
    • Contact: Damien MANDRY, MD, PhD; Phone Number: +33383154202; Email: d.mandry@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects will have an MRI examination	Device: MRI examination; All subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Anticipated): May 23, 2027
• Study Completion (Anticipated): May 23, 2027

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2021-A00243-38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No