HealthyEDENNCT05218460
Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects
A study testing MRI examination in people with Healthy and Pathology, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- MRI examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2022to 23 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- person with a pathology characterized by a functional and / or morphological alteration that may have an impact on the data collected (images, physiological signals, ...).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Nancy, 54000
Damien MANDRY, MD, PhD, +33383154202, d.mandry@chru-nancy.fr
About this study
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.
- Being tested
- MRI examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examinationDevice
All subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.
| Study group | Role | What they receive |
|---|---|---|
| All subjects will have an MRI examination | Experimental | Not described Receives: Device: MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality based on standard imaging quality criteria
The image quality will be appreciated visually at least by a radiologist or a researcher.
Measured: 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.
Measured: 6 months after the last inclusion
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: 6 months after the last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start23 May 2022
- Primary completion23 May 2027 (estimated)
- Study completion23 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro TEIXEIRA-GONDIM, MD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218460
- Sponsor's protocol ID
- 2021-A00243-38
- Acronym
- EDEN
- Status last verified
- Jun 2026
- First submitted
- 4 Jan 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 41428163Isaieva 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 37888339Leclere 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 41436119Isaieva 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 39738827Isaieva 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects
- ClinicalTrials.gov ID
- NCT05218460
- Acronym / sponsor ID
- EDEN / 2021-A00243-38
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 23 May 2027 (estimated)
- Study completion
- 23 May 2027 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects will have an MRI examination | Experimental | Device: MRI examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- person with a pathology characterized by a functional and / or morphological alteration that may have an impact on the data collected (images, physiological signals, ...).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI examinationAll subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development. | Device | All subjects will have an MRI examination |
Primary outcome
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Results publication: PubMed 41428163Megel 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.
- Results publication: PubMed 37888339Isaieva 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.
- Results publication: PubMed 41436119Leclere 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.
- Results publication: PubMed 39738827Isaieva 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.
- Results publication: PubMed 40031695Isaieva 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.
Related trials for Healthy
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Study of New Magnetic Resonance Imaging Methods of the Brain
Healthy Volunteer, Magnetic Resonance Imaging
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
RecruitingObservational study
Cytapheresis of Volunteer Donors
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI examination in people with Healthy and Pathology, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien MANDRY, MD, PhD (+33383154202, d.mandry@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality based on standard imaging quality criteria (time frame: 6 months after the last inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05218460, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.