MR7T-Healthy-PTX : Brain Exploration in Magnetic Resonanc... | NCT04369755

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

NCT04369755

Sponsor

Poitiers University Hospital

Status

Unknown status

Last Update Posted

Jan 27, 2022Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

MRI
PTX
BRAIN
7 TESLA

Interventions

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2020Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Apr 27, 2020

First Submission Date that Met QC Criteria

Apr 27, 2020

First Posted Date

Apr 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2022

Last Update Posted Date

Jan 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRI	Other	A MRI on PTX mode will be done on healthy subjects (approx. 90 min of sequences)	Other: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Other	A MRI in PTX mode will be done on healthy subject (approx. 90 min of sequences)	MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Evaluation of the body temperature	Measurement of body temperature in healthy volunteers using a forehead thermometer before and after examination	1 year
Evaluation of anxiety before, during and after the MRI

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided