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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
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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

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

Arm Intervention/treatment
Experimental: All subjects
All subjects will have an MRI examination
Device: MRI



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 %.

  6. 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).

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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, … ).

Information from the National Library of Medicine

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


Contacts
Contact: Valérie Laurent, MD,PhD v.laurent@chru-nancy.fr
Contact: Gabriela Hossu, PhD g.hossu@chru-nancy.fr

Locations
France
CHRU de Nancy Recruiting
Nancy, France, 5400
Contact: Valerie Laurent, Md, PhD         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Valérie Laurent, MD,PhD CHRU de Nancy
Principal Investigator: Jacques Felblinger, MD,PhD CHRU de Nancy

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02887053     History of Changes
Other Study ID Numbers: 2008-A01209-46
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Central Hospital, Nancy, France:
MRI
Healthy subjects