Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer (DOT)
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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Singapore、新加坡、169610
- National Cancer Centre Singapore
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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
取样方法
研究人群
描述
Inclusion Criteria:
- Patients receiving neoadjuvant chemotherapy for breast cancer.
- Patients with locally advanced breast tumours or large operable tumours who require neoadjuvant treatment for downstaging.
- Histological confirmation of invasive breast carcinoma.
- Patients with metastatic disease may be eligible if they have oligometastatic disease and breast surgery after neoadjuvant chemotherapy is planned.
- Signed informed consent
- Age equal to or more than 21 years
- Life expectancy greater than 12 weeks.
- ECOG performance status 0-2
Exclusion Criteria:
- Fungating or ulcerated tumours
- Inability to provide informed consent
- Anticipated inability to follow-up patient for response to chemotherapy
- Any contraindication to undergoing ultrasound, MRI, MMG or DOT
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Parameters derived from the optical images acquired with the DOT system
大体时间：These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
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The primary parameters derived from the optical images acquired with the DOT system include: The volume of tumor microvasculature V, the total haemoglobin concentration (THC), and the blood volume index BVI (=VC). Other available optical parameters are: blood oxygenation in the tumor microvasculature (SO2), its spatial distribution and dynamic fluctuation; dynamic blood perfusion. These parameters will be compared with histopathological response. |
These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation
大体时间：These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
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The change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation will be correlated with response based on clinical examination, ultrasound, MMG and MRI. Standard definitions for clinical response will be used to classify patients into four categories: complete response (CR), partial response (PR), progressive disease (PD) and stable disease (SD). |
These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
|
合作者和调查者
调查人员
- 首席研究员：Yoon Sim Yap, MBBS, FRACP、National Cancer Centre, Singapore
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
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 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.