Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- Optical signatures
研究概览
简要总结
The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients having a needle biopsy of a breast mass
排除标准
- 未提供
结局指标
主要结局
Optical signatures
时间窗: Day of procedure (less than 10 minutes)
The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast
次要结局
未报告次要终点
