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临床试验/NCT05175417
NCT05175417招募中不适用

Visualization of Neural Targets With 3T MRI

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Quantitative image quality metrics

研究概览

简要总结

Functional neurosurgery is dedicated to modulating aberrant neural circuits associated with a wide range of neurological conditions. Recently, technological advances in MRI have permitted marked improvements in the direct visualization of neural targets, which is necessary for the accurate targeting in functional neurosurgery procedures.

This research study focuses on imaging patient brains before their scheduled procedures by using a 3 tesla (T) MRI to provide higher resolution and quality brain images. The reason for this study is to assess the image quality using different MRI sequences or settings to improve the image resolution of the most common functional neurosurgery targets (e.g., subthalamic nucleus, globus pallidus, and thalamus) and compare the image quality of the brains in patients with healthy controls. Performing a preoperative MRI is standard-of-care for patients indicated for deep brain stimulation (DBS), gamma knife radiosurgery (GKRS), radiofrequency ablation (RFA), magnetic resonance-guided focused ultrasound (MRgFUS). MRI sequence parameters shown to improve the image quality of different neural structures in a recent literature review (Boutet et al. 2021) will be reproduced on the 3T MRI at Toronto Western Hospital.

详细描述

This is an exploratory prospective experimental study that will assess the ability of different MRI sequences to visualize common functional neurosurgical targets. Some neural structures (i.e., STN) are sometimes not visualized as well, particularly in older patients, when compared to healthy controls. The findings from this study should help in identifying the advanced sequences for direct visualization of these targets, that could then be used for improved preoperative planning of functional neurosurgical procedures.

Several advanced MRI sequences will be conducted when imaging patients or healthy participant. All advanced sequences have previously been published in the literature as viable, safe preoperative planning sequences for functional neurosurgical treatments at other centres. All MRI scans in this study will be acquired at the Toronto Western Hospital (TWH). For example, structural scans using sequences that can null or not receive signals from fluids in the brain and reduce geometric distortion (i.e., fluid attenuated inversion recovery (FLAIR)), null white matter signals (i.e., fast gray matter acquisition T1 inversion recovery (FGATIR)), and enhance the visualization of iron concentrated neural structures (i.e., quantitative susceptibility mapping (QSM)) will be performed. These advanced sequences will be compared to conventional structural MRI sequences (i.e., T1-weighted (T1W) or T2-weighted (T2W)) that are typically used for anatomical purposes and direct visualization of neural structures.

Ultimately, results from this study should enhance quality of care, clinical benefits, and data quality.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 85 years of age.
  • Preparing to undergo a functional neurosurgical intervention (e.g., DBS, RFA, GKR or MRgFUS) at TWH (not applicable for healthy volunteers).
  • Participants must be able to understand the purpose of this research and must sign the informed consent form.
  • Participants must understand that the role of this research is to enhance our understanding of brain functioning and that he/she will not directly or indirectly benefit from the study.

排除标准

  • Contraindication for an MRI (e.g., implanted cardiac device, metal in eyes, aneurysm clip, etc.).
  • Participants who have serious cognitive or psychological impairments and cannot give informed consent.
  • Participants who are unable to communicate effectively or efficiently (e.g., patients suffering from speech deficits (dysarthria, aphasia) or are non-English speaking).

结局指标

主要结局

Quantitative image quality metrics

时间窗: ≤ 1 week before surgery

Two quantitative image quality metrics commonly used are contrast-to-noise ratio (CNR) and signal-to-noise ratio (SNR). CNR (i.e., the ratio of the contrast between the signal in a given region and the background) is a measure of the contrast between the tissue of interest and the neighboring tissue. Similarly, SNR is a measure of the average image signal in a given region to the neighboring tissue or the noise around the region of interest.

Qualitative image quality metrics

时间窗: ≤ 1 week before surgery

Qualitative image quality metrics will assess the image quality and clinical acceptability of each scan in a randomized order. Each scan will be scored using a 5-point Likert scale by expert raters. An overall average score will be calculated for each MRI sequence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andres M. Lozano

University Professor

University Health Network, Toronto

研究点 (1)

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