Development, Implementation and Initiation of Normative Database Quantitative Ultra High Field MRI Paramaters

Not Applicable

• Conditions: Healthy
• Interventions: Procedure: acquisition of normative database with ultra high field MRI; Device: MRI

• Registration Number: NCT02402751
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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

Detailed Description

The key is that the goal of our projects is not only producing images of better quality than using a 3T scanner but also making images differently, by highlighting new contrasts and features of theses organs in order to improve the diagnosis and prognosis of neurological, psychiatric, cardiovascular and rheumatologic diseases.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-03-30
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-08-24
• Primary Completion: 2019-04
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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

Exclusion Criteria

• People staying in a sanitary or social establishment
• People in emergency situation
• People not wishing to be informed about anomalies in the MRI
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acquisition of normative database	MRI	Development, implementation and initiation of normative database (image and data) quantitative ultra high field MRI paramaters
Acquisition of normative database	acquisition of normative database with ultra high field MRI	Development, implementation and initiation of normative database (image and data) quantitative ultra high field MRI paramaters

Primary Outcome Measures

Name	Time	Method
qualitative validation concerning structure visible with high field MRI	4 years	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).

Secondary Outcome Measures

Name	Time	Method
acquisition of normative data and verification of the quality criteria obtained during the first phase	4 years	During the second phase, we will acquire normative data and verify the quality criteria of the first phase. Each quantitative variable will be extracted. After the acquisition of the first 30 volunteers for each parameter, the variance will be analyzed to assess the population distribution. Depending on the results, and issues raised by clinical research studies, other populations will be acquired

Trial Locations

Locations (1)

Assistance Publique - Hopitaux de Marseille; 🇫🇷 Marseille, France