Methodological Developments for Magnetic Resonance Imaging (MRI)

Healthy Subjects Clinical Trial

— METHODO  

Official title:

Développement Méthodologique de l'Imagerie Par Résonance Magnétique (IRM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887053
• Other study ID #: 2008-A01209-46
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: May 26, 2022

Study information

• Verified date: July 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1807
• Est. completion date: May 26, 2022
• Est. primary completion date: May 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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, … ).

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• MRI

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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