Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects (EDEN)
June 16, 2026 updated by: Pedro TEIXEIRA-GONDIM, MD, Central Hospital, Nancy, France
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
Study Type
Interventional
Enrollment (Estimated)
720
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
-
Nancy, France, 54000
- Recruiting
- CHRU de Nancy
-
Contact:
- Damien MANDRY, MD, PhD
- Phone Number: +33383154202
- Email: d.mandry@chru-nancy.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All subjects will have an 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
Time Frame: 6 months after the last inclusion
|
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
Time Frame: 6 months after the last inclusion
|
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.
Time Frame: 6 months after the last inclusion
|
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.
Time Frame: 6 months after the last inclusion
|
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.
Time Frame: 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).
|
6 months after the last inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Megel A, Isaieva K, Nohava L, Odille F, Fauvel M, Fischer B, Laistler E, Felblinger J, Henrot P. Preliminary evaluation of image quality in supine breast MRI using a dedicated wearable coil and accelerometer-based motion correction. Eur Radiol Exp. 2025 Dec 22;9(1):121. doi: 10.1186/s41747-025-00662-2.
- Isaieva K, Odille F, Laprie Y, Drouot G, Felblinger J, Vuissoz PA. Super-Resolved Dynamic 3D Reconstruction of the Vocal Tract during Natural Speech. J Imaging. 2023 Oct 20;9(10):233. doi: 10.3390/jimaging9100233.
- Leclere J, Isaieva K, Drouot G, Gillet R, Felblinger J, Vuissoz PA, Dubernard X. Quantifying symmetry in mandibular condyle motion: a real-time MRI approach. J Oral Facial Pain Headache. 2025 Dec;39(4):227-234. doi: 10.22514/jofph.2025.079. Epub 2025 Dec 12.
- Isaieva K, Leclere J, Paillart G, Drouot G, Felblinger J, Dubernard X, Vuissoz PA. Extraction of 3D trajectories of mandibular condyles from 2D real-time MRI. MAGMA. 2025 Feb;38(1):131-140. doi: 10.1007/s10334-024-01214-2. Epub 2024 Dec 30.
- Isaieva K, Weber N, Nohava L, Fischer B, Megel A, Henrot P, Micard E, Laistler E, Felblinger J, Odille F. Optimal Sensor Selection for Motion-Corrected Supine Breast MRI With a Wearable Coil. IEEE Trans Biomed Eng. 2025 Jul;72(7):2261-2268. doi: 10.1109/TBME.2025.3539386.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2022
Primary Completion (Estimated)
May 23, 2027
Study Completion (Estimated)
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)
June 17, 2026
Last Update Submitted That Met QC Criteria
June 16, 2026
Last Verified
June 1, 2026
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.