Development, Implementation and Initiation of Normative Database Quantitative Ultra High Field MRI Paramaters
1 other identifier
interventional
400
1 country
1
Brief Summary
The Centre for Magnetic Resonance in Biology and Medicine (CRMBM, UMR-CNRS 7339 AMU) obtained funding for a whole body NMR imaging at 7. It is the only MRI at 7T installed in a hospital in France (only two 7T MRI in France) and therefore a unique opportunity to develop new diagnostic approaches. The purpose of this study is to develop, implement and validate new MRI quantitative parameters derived from ultra high field MRI in order to characterize non-invasively with an unprecedented resolution and sensitivity, anatomy as well as certain physiological, hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart in healthy subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Mar 2015
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedAugust 24, 2016
August 1, 2016
4.1 years
March 25, 2015
August 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
qualitative validation concerning structure visible with high field MRI
the validation criteria are qualitative (contrast and visibility of anatomical structures usually visible 7T but not visible at 3T will be used to assess the sensitivity of images for each modality) and quantitative (signal to noise ratio (SNR), spatial and temporal resolution).
4 years
Secondary Outcomes (1)
acquisition of normative data and verification of the quality criteria obtained during the first phase
4 years
Study Arms (1)
Acquisition of normative database
EXPERIMENTALDevelopment, implementation and initiation of normative database (image and data) quantitative ultra high field MRI paramaters
Interventions
characterize non-invasively with an unprecedented resolution and sensitivity (high field MRI), anatomy as well as certain physiological, hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart
Eligibility Criteria
You may qualify if:
- People not presenting contraindications to the MRI (pacemaker, agitation, metallic brightness, claustrophobia etc.)
- People having no intra-physical object potentially conductive.
- People having no affection after detailed interrogation
You may not qualify if:
- People staying in a sanitary or social establishment
- People in emergency situation
- People not wishing to be informed about anomalies in the MRI
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique - Hopitaux de Marseille
Marseille, 13005, France
Study Officials
- PRINCIPAL INVESTIGATOR
Maxime GUYE, M.D
Assistance Publique Hopitaux De Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2015
First Posted
March 30, 2015
Study Start
March 1, 2015
Primary Completion
April 1, 2019
Study Completion
September 1, 2019
Last Updated
August 24, 2016
Record last verified: 2016-08