Pilot Investigation of Ultrasound Imaging and Spectroscopy as Early Indicators of Locally- Advanced Breast Cancer Response to Neoadjuvant Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Measuring the rate of treatment response between the treatment groups
研究概览
简要总结
This work explores the possibility of using ultrasound imaging and spectroscopy as a way of monitoring cell death, hence, tumour response to treatment. The hypothesis here is that it can be used as a way of monitoring early response to cancer treatment and predicting which patients continue on in their therapy to have a complete pathological response as a primary endpoint and tumour size decrease as a secondary endpoint. If this work is successful it could be used in the future early on in a cancer patient's treatment to predict whether or not a course of chemotherapy or radiotherapy is going to be successful. For example, in patients in which the analysis indicates a poor response the chemotherapy regimen could be changed to a more efficacious one or for those receiving radiotherapy predicted to have a poor response a radiosensitizing agent could be used to improve outcome.
详细描述
The primary objective in this study is to identify optimal ultrasound spectroscopy parameters that can be used as an early predictor of pathological complete or partial response in women with locally advanced breast cancer receiving treatment with chemotherapy or combined modality chemotherapy and radiotherapy. A secondary objective is to perform an inter-user variability comparison by comparing second site data analysis outcomes with central co-coordinating site data analysis. The overarching goal of this research is to transform the delivery of neoadjuvant chemotherapy using quantitative ultrasound, which is non-invasive, inexpensive and portable to assess breast cancer therapies through functional imaging, in which tumour cell death is detected. By detecting cell death early in a treatment on the order of hours to days, rather than traditional anatomical assessments that take place weeks to months after the completion of therapy, ineffective therapies could be switched to more efficacious treatments or aggressive salvage therapy which has shown to already benefit patients. This has the potential of improving survival in addition to sparing patients unnecessary side effects of treatments that may span weeks to months. The investigators will use these quantitative methods to evaluate treatments with neoadjuvant chemotherapy in women with locally advanced breast cancer. This investigation will track the spatio-temporal changes in quantitative ultrasound surrogates of treatment response during neoadjuvant chemotherapy of locally advanced breast cancer and use these parameters to adapt clinical treatment. The study specifically will expand on single- institution research underway and involve a second clinical site. Data will be independently collected and analysis carried out at that site and at the co-ordinating site for comparison evaluating technology-use feasibility and reproducibility of results.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed locally advanced breast carcinoma which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy
- •Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment
- •Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1
- •Life expectancy of at least 6 months
- •Patients should have the ability to understand and the willingness to sign a written informed consent document. Signed informed consent must be obtained prior to any study specific procedures
排除标准
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
结局指标
主要结局
Measuring the rate of treatment response between the treatment groups
时间窗: Up to 5 years
Correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with pathological complete or partial response
次要结局
- Inter-user variability comparison(Up to 5 years)
研究者
Dr. Gregory Czarnota
Radiation Oncologist and Clinician Scientist
Sunnybrook Health Sciences Centre