NCT04369755

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 25, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

April 27, 2020

Last Update Submit

January 26, 2022

Conditions

MRIPTXBRAIN7 TESLA

Keywords

MRIPTXBRAIN7 TESLA

Outcome Measures

Primary Outcomes (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).

    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 Outcomes (2)

  • Evaluation of the body temperature

    1 year

  • Evaluation of anxiety before, during and after the MRI

    1 year

Study Arms (1)

MRI

OTHER

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

Other: MRI

Interventions

MRIOTHER

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

MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Poitiers

Poitiers, 86000, France

RECRUITING

Central Study Contacts

Rémy GUILLEVIN, Pr

CONTACT

05.49.44.17.91remy.guillevin@chu-poitiers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 30, 2020

Study Start

June 25, 2020

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

January 27, 2022

Record last verified: 2022-01

Locations

FR(1)