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临床试验/NCT05755399
NCT05755399招募中不适用

Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor

University of Minnesota2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年10月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Test feasibility

研究概览

简要总结

Transcranial focused ultrasound (tFUS) offers a platform for non-invasive imaging and treatment of the brain and pathology of the brain -- allowing high resolution imaging in both spatial and temporal dimensions. Compared with the gold- standard for brain imaging, magnetic resonance imaging (MRI), ultrasound offers reduced contrast while providing improved sampling in time through a significantly more cost-effective approach. In addition, while MRI is used to guide invasive treatments, only ultrasound can offer treatments through three primary mechanisms: 1) neuromodulation, 2) blood brain barrier modulation, and thermal/mechanical ablation through high intensity focused ultrasound (HIFU). All three treatment options require targeting therapy through the skull, which remains a barrier to clinical translation. This proposal is to test the feasibility of acquiring noninvasive targeting imaging intraoperatively prior to clinically indicated cranial neurosurgery. By acquiring volumetric ultrasound images while coregistered to previously obtained stereotactic magnetic resonance imaging, the study will be able to compare the ability of tFUS to identify and focus on brain pathology.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Able to undergo informed consent
  • Scheduled and present for brain surgery
  • General Anesthesia planned
  • Neuronavigation used for surgery
  • Thin cut post-contrast imaging available for coregistration
  • At least 18 years of age

排除标准

  • Awake craniotomy planned
  • Unhealed wounds or infection of scalp
  • Diseases and conditions that would increase the morbidity and mortality of craniotomy and tumor resection (e.g. cardiopulmonary issues) in the opinion of the PI.
  • Pregnancy (also generally required for surgery)

研究组 & 干预措施

Experimental group

Experimental

Participants scheduled for brain surgery

干预措施: Brain imaging using transcranial focused ultrasound (tFUS) (Device)

结局指标

主要结局

Test feasibility

时间窗: baseline

For each participant feasibility is defined as 1 when any ultrasound slices are obtained and segmented. If tumor segmentation cannot be performed then this will be reported as 0, meaning not feasible. The result at the group level is a feasibility measure, i.e., the proportion of participants for whom the protocol was feasible.

次要结局

  • Volume assessment(Baseline)
  • Morphology assessment(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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