跳至主要内容
临床试验/NCT04369755
NCT04369755Unknown不适用

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 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
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).

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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).

研究组 & 干预措施

MRI

Other

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

干预措施: MRI (Other)

结局指标

主要结局

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).

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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