MR7T-Healthy-PTX : Brain Exploration in Magnetic Resonance Imaging in Parallel Transmission Mode (pTX) at 7 Tesla

Sponsor
Poitiers University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04369755
Collaborator
(none)
50
1
1
29.2
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MRI
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Pilote Study : Brain Exploration in Magnetic Resonance Imaging in Parallel Transmission Mode (pTX) at 7 Tesla on Healthy Subject at Poitiers University Hospital
Actual Study Start Date :
Jun 25, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: MRI

A MRI on PTX mode will be done on healthy subjects (approx. 90 min of sequences)

Other: MRI
A MRI in PTX mode will be done on healthy subject (approx. 90 min of sequences)

Outcome Measures

Primary Outcome Measures

  1. 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). [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 Outcome Measures

  1. Evaluation of the body temperature [1 year]

    Measurement of body temperature in healthy volunteers using a forehead thermometer before and after examination

  2. Evaluation of anxiety before, during and after the MRI [1 year]

    Measurement of the healthy subject's feelings about the exam (anxiety, heat, nausea) using a grid proposed at the end of the exam.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Poitiers Poitiers France 86000

Sponsors and Collaborators

  • Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT04369755
Other Study ID Numbers:
  • 2019-A02689-48
First Posted:
Apr 30, 2020
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Poitiers University Hospital

Study Results

No Results Posted as of Jan 27, 2022