Methodological Developments for Magnetic Resonance Imaging (MRI) (METHODO)
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|ClinicalTrials.gov Identifier: NCT02887053|
Recruitment Status : Unknown
Verified September 2016 by Central Hospital, Nancy, France.
Recruitment status was: Recruiting
First Posted : September 1, 2016
Last Update Posted : September 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Device: MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1650 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2017|
Experimental: All subjects
All subjects will have an MRI examination
- 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
- T1/T2 Quantitative sub studies [ Time Frame: 6 months after the last inclusion ]For quantitative studies such as T1/T2 studies a T1/T2 quantification will be calculated. These parameters will be reported in ms.
- Brain Functional MRI sub studies [ Time Frame: 6 months after the last inclusion ]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.
- Cardiac function MRI sub studies: volume [ Time Frame: 6 months after the last inclusion ]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.
- Cardiac mass MRI sub studies: mass [ Time Frame: 6 months after the last inclusion ]For cardiac imaging, cardiac function will be evaluated. LV and RV mass index will be measured and reported in g/m2.
- Cardiac function MRI sub studies: ejection fraction [ Time Frame: 6 months after the last inclusion ]For cardiac imaging, cardiac function will be evaluated. Ejection fraction for both ventricles will be calculated and reported in %.
- Diffusion weighted MRI sub studies [ Time Frame: 6 months after the last inclusion ]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).
- Diffusion tensor MRI sub studies [ Time Frame: 6 months after the last inclusion ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887053
|Contact: Valérie Laurent, MD,PhDemail@example.com|
|Contact: Gabriela Hossu, PhDfirstname.lastname@example.org|
|CHRU de Nancy||Recruiting|
|Nancy, France, 5400|
|Contact: Valerie Laurent, Md, PhD|
|Principal Investigator:||Valérie Laurent, MD,PhD||CHRU de Nancy|
|Principal Investigator:||Jacques Felblinger, MD,PhD||CHRU de Nancy|