Healthy SubjectsMETHODONCT02887053
Methodological Developments for Magnetic Resonance Imaging (MRI)
A study testing MRI in people with Healthy Subjects, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose of this study is to optimize clinical MR protocols and to validate MR acquisition parameters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,807 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to 26 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 able to give an informed consent,
- to have underwent a pre-inclusion medical examination,
- to present no contraindication to MR examination,
- to be enrolled in a social security plan.
Who cannot join
- subject refusal,
- subject under a measure of legal protection,
- any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, … ).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Développement Méthodologique de l'Imagerie Par Résonance Magnétique (IRM)
The purpose of this study is to optimize clinical MR protocols and to validate MR acquisition parameters.
- Conditions
- Healthy Subjects
- Being tested
- MRI
- Keywords
- MRI, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | All subjects will have an MRI examination Receives: Device: MRI |
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
Image quality criteria will be :
- Signal to Noise Ratio and Contrast to Noise Ratio measured in arbitrary units.
- absence of blurring and artefacts will be assessed by at least one radiologist according to an ordinal scale
Measured: 6 months after the last inclusion
Secondary outcomes (7)
T1/T2 Quantitative sub studies
For quantitative studies such as T1/T2 studies a T1/T2 quantification will be calculated. These parameters will be reported in ms.
Measured: 6 months after the last inclusion
Brain Functional MRI sub studies
For functional MRI studies, brain activity will be described in terms of brain localisation based on blood oxygen level-dependent signal variation and its intensity.
Measured: 6 months after the last inclusion
Cardiac function MRI sub studies: volume
For cardiac imaging, cardiac function will be evaluated. Parameters such as left ventricle (LV) and right ventricle (RV) end-diastolic volumes end-systolic volumes will be measured and reported in mL/m².
Measured: 6 months after the last inclusion
Cardiac mass MRI sub studies: mass
For cardiac imaging, cardiac function will be evaluated. LV and RV mass index will be measured and reported in g/m2.
Measured: 6 months after the last inclusion
Cardiac function MRI sub studies: ejection fraction
For cardiac imaging, cardiac function will be evaluated. Ejection fraction for both ventricles will be calculated and reported in %.
Measured: 6 months after the last inclusion
Diffusion weighted MRI sub studies
For diffusion studies, the apparent diffusion coefficient (ADC) whic is a measure of the magnitude of diffusion (of water molecules) within tissue will be estimated (mm2/s).
Measured: 6 months after the last inclusion
Diffusion tensor MRI sub studies
The fractional anisotropy (FA) which is a scalar value between zero and one, which describes the degree of anisotropy of a diffusion process, could also be estimated.
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 Sep 2016 (estimated)
- Study startNov 2008
- Primary completion26 May 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- 1,807 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valérie LAURENT, Central Hospital, Nancy, France
- Investigators
- Valérie Laurent, MD,PhD, Principal investigator, CHRU de NancyJacques Felblinger, MD,PhD, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887053
- Sponsor's protocol ID
- 2008-A01209-46
- Acronym
- METHODO
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2016
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Isaieva K, Meullenet C, Vuissoz PA, Fauvel M, Nohava L, Laistler E, Zeroual MA, Henrot P, Felblinger J, Odille F. Feasibility of online non-rigid motion correction for high-resolution supine breast MRI. Magn Reson Med. 2023 Nov;90(5):2130-2143. doi: 10.1002/mrm.29768. Epub 2023 Jun 28.
PubMed 37379467Meullenet C, Isaieva K, Odille F, Dessale C, Felblinger J, Henrot P. Evaluation of Image Quality of Motion-Corrected Supine Breast MRI. Curr Probl Diagn Radiol. 2023 Nov-Dec;52(6):493-500. doi: 10.1067/j.cpradiol.2023.05.013. Epub 2023 May 11.
PubMed 37258350Isaieva K, Leclere J, Felblinger J, Gillet R, Dubernard X, Vuissoz PA. Methodology for quantitative evaluation of mandibular condyles motion symmetricity from real-time MRI in the axial plane. Magn Reson Imaging. 2023 Oct;102:115-125. doi: 10.1016/j.mri.2023.05.006. Epub 2023 May 13.
PubMed 37187265Douros IK, Xie Y, Dourou C, Isaieva K, Vuissoz PA, Felblinger J, Laprie Y. 3D Dynamic Spatiotemporal Atlas of the Vocal Tract during Consonant-Vowel Production from 2D Real Time MRI. J Imaging. 2022 Aug 25;8(9):227. doi: 10.3390/jimaging8090227.
PubMed 36135393Isaieva K, Fauvel M, Weber N, Vuissoz PA, Felblinger J, Oster J, Odille F. A hardware and software system for MRI applications requiring external device data. Magn Reson Med. 2022 Sep;88(3):1406-1418. doi: 10.1002/mrm.29280. Epub 2022 May 4.
PubMed 35506503Draveny R, Ambarki K, Han F, Hilbert T, Laurent V, Morel O, Bertholdt C, Beaumont M. Comparison of T2 Quantification Strategies in the Abdominal-Pelvic Region for Clinical Use. Invest Radiol. 2022 Jun 1;57(6):412-421. doi: 10.1097/RLI.0000000000000852. Epub 2022 Jan 10.
PubMed 34999669Le Bars AL, Moulin K, Ennis DB, Felblinger J, Chen B, Odille F. In Vivo Super-Resolution Cardiac Diffusion Tensor MRI: A Feasibility Study. Diagnostics (Basel). 2022 Mar 31;12(4):877. doi: 10.3390/diagnostics12040877.
PubMed 35453925Isaieva K, Laprie Y, Leclere J, Douros IK, Felblinger J, Vuissoz PA. Multimodal dataset of real-time 2D and static 3D MRI of healthy French speakers. Sci Data. 2021 Oct 1;8(1):258. doi: 10.1038/s41597-021-01041-3.
PubMed 34599194Soullie P, Missoffe A, Ambarki K, Felblinger J, Odille F. MR electrical properties imaging using a generalized image-based method. Magn Reson Med. 2021 Feb;85(2):762-776. doi: 10.1002/mrm.28458. Epub 2020 Aug 11.
PubMed 32783236Isaieva K, Laprie Y, Odille F, Douros IK, Felblinger J, Vuissoz PA. Measurement of Tongue Tip Velocity from Real-Time MRI and Phase-Contrast Cine-MRI in Consonant Production. J Imaging. 2020 May 13;6(5):31. doi: 10.3390/jimaging6050031.
PubMed 34460733Dos Reis JE, Odille F, Petitmangin G, Guillou A, Vuissoz PA, Felblinger J, Oster J. Broadband electrocardiogram acquisition for improved suppression of MRI gradient artifacts. Physiol Meas. 2020 May 7;41(4):045004. doi: 10.1088/1361-6579/ab7b8e.
PubMed 32120353Dos Reis JE, Soullie P, Oster J, Palmero Soler E, Petitmangin G, Felblinger J, Odille F. Reconstruction of the 12-lead ECG using a novel MR-compatible ECG sensor network. Magn Reson Med. 2019 Nov;82(5):1929-1945. doi: 10.1002/mrm.27854. Epub 2019 Jun 14.
PubMed 31199011Delbany M, Bustin A, Poujol J, Thomassin-Naggara I, Felblinger J, Vuissoz PA, Odille F. One-millimeter isotropic breast diffusion-weighted imaging: Evaluation of a superresolution strategy in terms of signal-to-noise ratio, sharpness and apparent diffusion coefficient. Magn Reson Med. 2019 Apr;81(4):2588-2599. doi: 10.1002/mrm.27591. Epub 2018 Dec 10.
PubMed 30536764Bustin A, Voilliot D, Menini A, Felblinger J, de Chillou C, Burschka D, Bonnemains L, Odille F. Isotropic Reconstruction of MR Images Using 3D Patch-Based Self-Similarity Learning. IEEE Trans Med Imaging. 2018 Aug;37(8):1932-1942. doi: 10.1109/TMI.2018.2807451. Epub 2018 Feb 19.
PubMed 29994581Dupont AC, Poussel M, Hossu G, Marie PY, Chenuel B, Felblinger J, Mandry D. Aortic compliance variation in long male distance triathletes: A new insight into the athlete's artery? J Sci Med Sport. 2017 Jun;20(6):539-542. doi: 10.1016/j.jsams.2016.10.009. Epub 2016 Oct 29.
PubMed 27838232
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Développement Méthodologique de l'Imagerie Par Résonance Magnétique (IRM)
- ClinicalTrials.gov ID
- NCT02887053
- Acronym / sponsor ID
- METHODO / 2008-A01209-46
- Conditions
- Healthy Subjects
- Keywords
- MRI, Healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,807 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Nov 2008 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 1 Sep 2016 (estimated)
- 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 purpose of this study is to optimize clinical MR protocols and to validate MR acquisition parameters.
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 | Experimental | Device: MRIAll subjects will have an 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 able to give an informed consent,
- to have underwent a pre-inclusion medical examination,
- to present no contraindication to MR examination,
- to be enrolled in a social security plan.
Key exclusion criteria (3 listed)
- subject refusal,
- subject under a measure of legal protection,
- any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, … ).
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 | Device | All subjects |
Primary outcome
Image quality based on standard imaging quality criteria
Time frame: 6 months after the last inclusion
Image quality criteria will be : * Signal to Noise Ratio and Contrast to Noise Ratio measured in arbitrary units. * absence of blurring and artefacts will be assessed by at least one radiologist according to an ordinal scale
7 secondary outcomes
T1/T2 Quantitative sub studies
Time frame: 6 months after the last inclusion
Brain Functional MRI sub studies
Time frame: 6 months after the last inclusion
Cardiac function MRI sub studies: volume
Time frame: 6 months after the last inclusion
Cardiac mass MRI sub studies: mass
Time frame: 6 months after the last inclusion
Cardiac function MRI sub studies: ejection fraction
Time frame: 6 months after the last inclusion
Diffusion weighted MRI sub studies
Time frame: 6 months after the last inclusion
Diffusion tensor MRI sub studies
Time frame: 6 months after the last inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Results publication: PubMed 37379467Isaieva K, Meullenet C, Vuissoz PA, Fauvel M, Nohava L, Laistler E, Zeroual MA, Henrot P, Felblinger J, Odille F. Feasibility of online non-rigid motion correction for high-resolution supine breast MRI. Magn Reson Med. 2023 Nov;90(5):2130-2143. doi: 10.1002/mrm.29768. Epub 2023 Jun 28.
- Results publication: PubMed 37258350Meullenet C, Isaieva K, Odille F, Dessale C, Felblinger J, Henrot P. Evaluation of Image Quality of Motion-Corrected Supine Breast MRI. Curr Probl Diagn Radiol. 2023 Nov-Dec;52(6):493-500. doi: 10.1067/j.cpradiol.2023.05.013. Epub 2023 May 11.
- Results publication: PubMed 37187265Isaieva K, Leclere J, Felblinger J, Gillet R, Dubernard X, Vuissoz PA. Methodology for quantitative evaluation of mandibular condyles motion symmetricity from real-time MRI in the axial plane. Magn Reson Imaging. 2023 Oct;102:115-125. doi: 10.1016/j.mri.2023.05.006. Epub 2023 May 13.
- Results publication: PubMed 36135393Douros IK, Xie Y, Dourou C, Isaieva K, Vuissoz PA, Felblinger J, Laprie Y. 3D Dynamic Spatiotemporal Atlas of the Vocal Tract during Consonant-Vowel Production from 2D Real Time MRI. J Imaging. 2022 Aug 25;8(9):227. doi: 10.3390/jimaging8090227.
- Results publication: PubMed 35506503Isaieva K, Fauvel M, Weber N, Vuissoz PA, Felblinger J, Oster J, Odille F. A hardware and software system for MRI applications requiring external device data. Magn Reson Med. 2022 Sep;88(3):1406-1418. doi: 10.1002/mrm.29280. Epub 2022 May 4.
- Results publication: PubMed 34999669Draveny R, Ambarki K, Han F, Hilbert T, Laurent V, Morel O, Bertholdt C, Beaumont M. Comparison of T2 Quantification Strategies in the Abdominal-Pelvic Region for Clinical Use. Invest Radiol. 2022 Jun 1;57(6):412-421. doi: 10.1097/RLI.0000000000000852. Epub 2022 Jan 10.
- Results publication: PubMed 35453925Le Bars AL, Moulin K, Ennis DB, Felblinger J, Chen B, Odille F. In Vivo Super-Resolution Cardiac Diffusion Tensor MRI: A Feasibility Study. Diagnostics (Basel). 2022 Mar 31;12(4):877. doi: 10.3390/diagnostics12040877.
- Results publication: PubMed 34599194Isaieva K, Laprie Y, Leclere J, Douros IK, Felblinger J, Vuissoz PA. Multimodal dataset of real-time 2D and static 3D MRI of healthy French speakers. Sci Data. 2021 Oct 1;8(1):258. doi: 10.1038/s41597-021-01041-3.
- Results publication: PubMed 32783236Soullie P, Missoffe A, Ambarki K, Felblinger J, Odille F. MR electrical properties imaging using a generalized image-based method. Magn Reson Med. 2021 Feb;85(2):762-776. doi: 10.1002/mrm.28458. Epub 2020 Aug 11.
- Results publication: PubMed 34460733Isaieva K, Laprie Y, Odille F, Douros IK, Felblinger J, Vuissoz PA. Measurement of Tongue Tip Velocity from Real-Time MRI and Phase-Contrast Cine-MRI in Consonant Production. J Imaging. 2020 May 13;6(5):31. doi: 10.3390/jimaging6050031.
- Results publication: PubMed 32120353Dos Reis JE, Odille F, Petitmangin G, Guillou A, Vuissoz PA, Felblinger J, Oster J. Broadband electrocardiogram acquisition for improved suppression of MRI gradient artifacts. Physiol Meas. 2020 May 7;41(4):045004. doi: 10.1088/1361-6579/ab7b8e.
- Results publication: PubMed 31199011Dos Reis JE, Soullie P, Oster J, Palmero Soler E, Petitmangin G, Felblinger J, Odille F. Reconstruction of the 12-lead ECG using a novel MR-compatible ECG sensor network. Magn Reson Med. 2019 Nov;82(5):1929-1945. doi: 10.1002/mrm.27854. Epub 2019 Jun 14.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Valérie Laurent, MD,PhD principal investigator
CHRU de Nancy
Jacques Felblinger, MD,PhD principal investigator
CHRU de Nancy
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 in people with Healthy Subjects, 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: finished, as of the sponsor's last update on 5 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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). 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 NCT02887053, which also lists 28 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 5 Mar 2026.