Recruiting NCT05218460
Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI examination.
- Who it may be relevant to
- Registry conditions: Healthy, Pathology. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device MRI examination
All subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.
Primary outcome measures
- Image quality based on standard imaging quality criteria [Time frame: 6 months after the last inclusion]
- Signal quality based on standard signal quality criteria [Time frame: 6 months after the last inclusion]
Secondary outcome measures (3)
- 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]
- 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]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHRU de Nancy — Nancy
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. PMID 41428163
- 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. PMID 37888339
- 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. PMID 41436119
- 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. PMID 39738827
- 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. PMID 40031695
Identifiers
NCT: NCT05218460 · 2021-A00243-38