Methodological Developments for Magnetic Resonance Imaging (MRI)

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Device: MRI

• Registration Number: NCT02887053
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The purpose of this study is to optimize clinical MR protocols and to validate MR acquisition parameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-01
• Primary Completion: 2022-05-26
• Study Completion: 2022-05-26
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1807

Inclusion Criteria

• 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.

Exclusion Criteria

• subject refusal,
• subject under a measure of legal protection,
• any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, ... ).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	MRI	All subjects will have an MRI examination

Primary Outcome Measures

Name	Time	Method
Image quality based on standard imaging quality criteria	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

Secondary Outcome Measures

Name	Time	Method
T1/T2 Quantitative sub studies	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	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 mass MRI sub studies: mass	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: volume	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 function MRI sub studies: ejection fraction	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	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	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.

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Nancy, France