Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Parameters derived from the optical images acquired with the DOT system
研究概览
简要总结
The aim of the study is to determine if DOT can detect response early in breast cancer patients undergoing neoadjuvant chemotherapy.
详细描述
The pilot study will enrol up to ten patients over one year. Patients receiving neoadjuvant chemotherapy for breast cancer will undergo baseline clinical examination, mammography, ultrasound, MRI and DOT before commencement of treatment. DOT will be repeated at 1,3,6 weeks after chemotherapy, and at the end of each chemotherapy regimen. Ultrasound will be repeated every 6 weeks and at the end of treatment. Mammography and MRI will be repeated once at the end of treatment before surgery. A breast pathologist will evaluate the subtype of breast cancer and the pathologic response of the operative specimen at the end of treatment. Patient satisfaction questionnaires will be administered to evaluate their preferences for DOT, ultrasound, mammography and MRI scanning at the beginning and the end of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Parameters derived from the optical images acquired with the DOT system
时间窗: These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
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.
次要结局
- Change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation(These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months)
研究者
Yap Yoon Sim
Senior Consultant
National Cancer Centre, Singapore