An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 2
- 主要终点
- Identification of the optical signatures of breast tissue.
研究概览
简要总结
Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Clinical diagnosis of Breast Cancer
排除标准
- 未提供
结局指标
主要结局
Identification of the optical signatures of breast tissue.
时间窗: Day of procedure
The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue.
次要结局
未报告次要终点
