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

MRI Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04369755
• Other study ID #: 2019-A02689-48
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2020
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Poitiers University Hospital
• Contact: Rémy GUILLEVIN, Pr
• Phone: 05.49.44.17.91
• Email: remy.guillevin[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• 7 TESLA
• BRAIN
• MRI
• PTX

Intervention

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

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	1 year
Secondary	Evaluation of the body temperature	Measurement of body temperature in healthy volunteers using a forehead thermometer before and after examination	1 year
Secondary	Evaluation of anxiety before, during and after the MRI	Measurement of the healthy subject's feelings about the exam (anxiety, heat, nausea) using a grid proposed at the end of the exam.	1 year