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

Not Applicable

Recruiting

• Conditions: Healthy; Pathology
• Interventions: Device: MRI examination

• Registration Number: NCT05218460
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-02-01
• Study Start: 2022-05-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-07
• Primary Completion: 2027-05-23
• Study Completion: 2027-05-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects will have an MRI examination	MRI examination	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Nancy, France