Methodological Developments for Magnetic Resonance Imaging (MRI) (METHODO)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: MRI

• Study Type: Interventional
• Enrollment (Actual): 1807
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nancy, France, 5400
    • CHRU de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects; All subjects will have an MRI examination	Device: MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months after the last inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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 %.	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).	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.	6 months after the last inclusion

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Valérie Laurent, MD,PhD, CHRU de Nancy; Principal Investigator: Jacques Felblinger, MD,PhD, CHRU de Nancy

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2008
• Primary Completion (Actual): May 26, 2022
• Study Completion (Actual): May 26, 2022

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Healthy subjects
• Other Study ID Numbers: 2008-A01209-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO