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Clinical Trials/NCT04369755
NCT04369755
Unknown
Not Applicable

Pilote Study : Brain Exploration in Magnetic Resonance Imaging in Parallel Transmission Mode (pTX) at 7 Tesla on Healthy Subject at Poitiers University Hospital

Poitiers University Hospital1 site in 1 country50 target enrollmentJune 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
MRI
Sponsor
Poitiers University Hospital
Enrollment
50
Locations
1
Primary Endpoint
Evaluate the improvement of the Signal to Noise Ratio (SNR) in parallel transmission mode (pTx) versus without pTx at 7.0 T on different cerebral anatomical regions/structures (central gray nuclei, cerebellum, white matter, cortex).
Last Updated
4 years ago

Overview

Brief Summary

Magnetic resonance imaging (MRI) is a non-invasive imaging modality used in routine clinical practice for clinical diagnosis by visualizing the anatomical structure and in vivo function of certain organs. The development of ultra-high field MRI systems with 7.0-T or higher, gives access to a new field of exploration of the human body by improving the speed of acquisition but also a better signal-to-noise ratio (SNR) and better resolution. In order to fully exploit the potential of these ultra-high field MRI scanners, various technical issues must be adressed. Indeed, the non-uniformity of the transmission field is one of them leading to non-uniform images with spatially varying contrast. Thus the pTX (parallel transmission) mode using multiple transmission channels allows spatial and temporal control over the RF waves.

Registry
clinicaltrials.gov
Start Date
June 25, 2020
End Date
December 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years old
  • Subject with no MRI contraindications (metallic shine, pacemaker)
  • Free subject, without guardianship or curatorship or subordination
  • A person affiliated to or beneficiary of a social security scheme.
  • Informed and signed consent by the healthy volunteer after clear and fair information about the study

Exclusion Criteria

  • Subject with a contraindication to MRI (pregnancy, ocular metallic foreign body (accidental or other shrapnel); pacemaker (cardiac stimulator), implantable defibrillator, non MRI 7.0 T compatible neurostimulator, cochlear implants and generally any irremovably implanted electronic medical device; metallic heart valve, vascular clips formerly implanted on cranial aneurysm), metallic prostheses.
  • Healthy volunteers suffering from claustrophobia
  • Persons not benefiting from a Social Security scheme or not benefiting from it through a third party.
  • Persons benefiting from reinforced protection, i.e. minors, pregnant and breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally, patients in emergency situations.
  • Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).

Outcomes

Primary Outcomes

Evaluate the improvement of the Signal to Noise Ratio (SNR) in parallel transmission mode (pTx) versus without pTx at 7.0 T on different cerebral anatomical regions/structures (central gray nuclei, cerebellum, white matter, cortex).

Time Frame: 1 year

The main evaluation criterion is the value of the signal-to-noise ratio in a global way but also by a unit comparison approach (voxel to voxel). It will be a question of linking these variations to the flip angles but also to the probable inhomogeneities of the B1+ field.

Secondary Outcomes

  • Evaluation of the body temperature(1 year)
  • Evaluation of anxiety before, during and after the MRI(1 year)

Study Sites (1)

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