Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 4
- 主要终点
- Diagnostic tool
研究概览
简要总结
Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.
详细描述
The Researcher developed a diagnostic device called Diffuse Optical Spectroscopy Imaging is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues.
Diffuse Optical Spectroscopy Imaging can images tissue hemoglobin , oxygen saturation, blood volume fraction, water content, fat content and cellular structure. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development.
There is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. However, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
- •Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy
排除标准
- •Female pregnant and age less than 21 years old and have no diagnosis of breast cancer
结局指标
主要结局
Diagnostic tool
时间窗: 12 weeks
Diffuse Optical Spectroscopy Imaging Breast Cancer Tumor in the response of Chemotherapy
次要结局
未报告次要终点
研究者
Beckman Laser Institute and Medical Center
David Hsiang, M.D., Division of Surgical Oncology
University of California, Irvine