Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI
Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging in a Multi-Center Setting
研究概览
详细说明
There is considerable interest in developing imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy (NAC), which is chemotherapy given before surgical removal of the tumor, both prior to and as early as possible during the course of treatment. The efficacy and practicality of conventional imaging approaches in the NAC setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging (DOSI) is an experimental imaging method that allows patients to be followed before and during treatment with a cost-effective, bedside, handheld scanning probe. DOSI is a non-invasive technology developed at the University of California, Irvine Beckman Laser Institute. Studies will be performed at seven clinical sites on approximately 200 suspected breast cancer patients, of which 150 are expected to undergo neoadjuvant chemotherapy (NAC).
As a primary aim, the investigators will evaluate whether DOSI can predict NAC pathologic complete response (pCR), which is defined as no tumor cell left in the resected tissue at surgery) by the mid-point of the therapy regimen. As non-invasive DOSI is obtained rapidly with no risk/discomfort, this experimental imaging modality could be used as an indicator of pathologic response which has been an established indicator of long-term survival. The investigators long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can be used to help inform medical decisions on chemotherapy regimen, duration, and timing of surgery, thereby maximizing therapeutic response and minimizing unnecessary toxicity.
研究类型
阶段
- 不适用
联系人和位置
学习地点
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California
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Costa Mesa、California、美国、92627
- Pacific Breast Care Clinic
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Irvine、California、美国、92612
- Beckman Laser Institute University of California Irvine
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Irvine、California、美国、92612
- University of California, Irvine Medical Center
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San Francisco、California、美国、94110
- University of California San Francisco
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Females between the ages of 21 and 80. Specific to Study part #1
- Diagnosed with a Breast Imaging-Reporting and Data System score of 4 or higher breast abnormality greater than 1cm in size Specific to Study part #2
- Enrolled in study part #1
- Diagnosed with histologically-proven invasive breast cancer
- Prescribed neoadjuvant chemotherapy for breast cancer
Exclusion Criteria:
- Pregnant
- Unable to give written, informed consent.
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:DOSI
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Breast tissue properties scanning
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Concentration of oxy-hemoglobin (HbO2), in blood.
大体时间:through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
Concentration of deoxy-hemoglobin (HHb) in blood.
大体时间:through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
Concentration of total hemoglobin in blood.
大体时间:through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
Water content of tissue (%)
大体时间:through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
Bulk lipid in tissue (%)
大体时间:through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
合作者和调查者
调查人员
- 首席研究员:Bruce J Tromberg, PhD、Beckman Laser Institute
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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