Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Intraoperative determination of the location of critical brain functions.
研究概览
简要总结
This clinical trial studies optical imaging in assessing activity during surgery in patients with brain tumors. New procedures, such as optical spectroscopy, may help doctors maximally remove brain tumors and minimize damage to normal brain.
详细描述
PRIMARY OBJECTIVES:
I. To develop the instrumentation to achieve real time processing and display of intraoperative 2-dimensional optical imaging and spectroscopy (i2DOS) maps in the operating arena.
II. To examine the timing and spatial involvement of human cortex intraoperatively to different stimuli using i2DOS.
OUTLINE: Patients undergo i2DOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Neurosurgical patient population in the City of Hope brain and spinal tumor neurosurgical programs that have been diagnosed with a brain tumor.
- •Only lucid patients qualified to consent to neurosurgical procedure will be approached for participation in this study.
- •We do intend to enroll subjects with potentially terminal brain tumors. Due to the potential benefit of intraoperative mapping, we are not planning to exclude these subjects.
- •Patients with any type of brain tumor will be eligible for participation.
- •All subjects must have the ability to understand and the willingness to sign a written informed consent.
排除标准
- •There are no exclusion criteria except for individuals without a brain tumor and the location of the craniotomy. If the exposed area of brain is not compatible with peripheral stimuli or volitional activity the subject cannot be enrolled.
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
结局指标
主要结局
Intraoperative determination of the location of critical brain functions.
时间窗: Day 1 post surgery
We will examine the timing and spatial involvement of human cortex intraoperatively to different stimuli using i2DOS. Stimulus parameters will be varied to investigate stimulus-response relationships. We will study areas of sensori-motor and language cortex using customary stimuli for evoked potentials (i.e. transcutaneous electrical nerve stimulation), tactile stimuli for exposed cortical dermatome representations, and language tasks for cortical language representations. Results will be correlated with intraoperative electrophysiological measures.
Determination of the effectiveness of intraoperative optical imaging technology and optical spectroscopy.
时间窗: Day 1 post surgery
Optical reflectance images will be analyzed by pixel by-pixel subtraction of a control trial and a stimulation trial. This subtracted image will then be divided by the control image to normalize for differences between subjects and trials. These ratios thus represent proportional changes from baseline.
次要结局
未报告次要终点