Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal Tissues From Abnormal Tissues During Brain Tumor Resection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon
研究概览
简要总结
The purpose of the study is to do a direct comparison of the CONVIVO system (camera imaging device) with our normal Stanford pathology process. CONVIVO system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound.
详细描述
Primary Objective:
The primary objective of this study is to determine the feasibility of using the CONVIVO imaging system to identify tumor type.
Secondary Objective: The secondary objectives are to determine the average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning, and to describe the ability of the CONVIVO imaging
-To describe the ability of the CONVIVO imaging system to generate readable images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •The subject demonstrates the ability to understand and the willingness to sign a written informed consent document.
- •The subject is suspected to be suffering from following brain tumor: low-grade glioma, high grade-glioma, metastases, or meningioma.
- •The subject has been deemed eligible for surgical resection by a practicing Stanford physician.
- •Macroscopic tumor visualization using IV infusion of 500mg sodium fluorescein is planned as part of the subject's standard of care treatment.
- •The subject is older than 18 years.
- •The subject is receiving their surgery at Stanford Hospital.
排除标准
- •* Patients with any kind of contraindication to the use of fluorescein
结局指标
主要结局
Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon
时间窗: 12 months
Feasibility is defined as a match between the pathologist determination of a mock diagnosis of type of tumor using CONVIVO images of the planned resection area and the pathologist's cryosection-derived diagnosis used in the course of surgery. This outcome will be expressed as a number without dispersion.
次要结局
- Average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning(12 months)
- Ability of the CONVIVO system capture a readable image(12 months)