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RecruitingNCT05218460EDENUpdated Jun 17, 2026

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

An interventional study of MRI examination in Healthy and Pathology, sponsored by Central Hospital, Nancy, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Other

From the registry’s dates

  • Started May 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
720
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
  • Pathology
03

In context

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
720 participants (estimated)

Study arms

  • Experimental
    All subjects will have an MRI examination

    Device: MRI examination

Interventions

  • DeviceMRI examination

    All subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.

06

What researchers measure

Primary outcomes

  1. Image quality based on standard imaging quality criteria

    The image quality will be appreciated visually at least by a radiologist or a researcher.

    Time frame: 6 months after the last inclusion

  2. Signal quality based on standard signal quality criteria

    The signal quality will be appreciated visually at least by a radiologist or a researcher.

    Time frame: 6 months after the last inclusion

Secondary outcomes

  1. 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.

    Time frame: 6 months after the last inclusion

  2. 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.

    Time frame: 6 months after the last inclusion

  3. 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).

    Time frame: 6 months after the last inclusion

07

Study locations

1 of 1 sites recruiting
  • CHRU de Nancy
    Nancy, 54000, France
    Recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 40031695 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05218460
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Pedro TEIXEIRA-GONDIM, MD (Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Feb 1, 2022
Start date
May 23, 2022
Primary completion
May 23, 2027 (estimated)
Completion
May 23, 2027 (estimated)
Last update
Jun 17, 2026

Study contacts

Damien MANDRY, MD, PhD
Contact
d.mandry@chru-nancy.fr
+33383154202
Gabriela HOSSU, PhD
Contact
g.hossu@chru-nancy.fr
+33383155096

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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