Investigation of Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Correlation of quantitative ultrasound parameters to the histopathological properties of suspected breast cancer tissues.
研究概览
简要总结
The purpose of the study is to test the hypothesis that quantitative ultrasound techniques including spectroscopy may be used as a non-invasive biomarker for characterization of suspected breast cancers. The main goal is to select and identify an optimal set of quantitative ultrasound parameters that can be used, non-invasively, to characterize suspected breast cancers, as identified based on the histopathology reports on core biopsy specimens, surgery reports, or radiology reports. Primary endpoint will correlate quantitative ultrasound parameters to the histopathological properties, as determined from pathology reports on core biopsy specimens, surgery reports, or radiology reports. The secondary endpoint in this study will include correlating the results of ultrasound-based breast cancer characterization with 2 and 5-years clinical outcomes.
详细描述
This project is an observational/early validation study in human subjects that will use ultrasound imaging and spectroscopy to characterize suspected breast cancers. Patients will be imaged with ultrasound, and the acquired data will be analyzed using quantitative ultrasound techniques, in conjunction with textural analysis on generated parametric images. Results of quantitative ultrasound data analysis for these breast lumps will be compared to and correlated with histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women or men with suspected breast cancer
- •Patients should have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering in the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration.
- •Receiving any other investigational agents.
- •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
Correlation of quantitative ultrasound parameters to the histopathological properties of suspected breast cancer tissues.
时间窗: Up to 2 years
As a primary endpoint, correlate changes in ultrasound backscatter parameters obtained using spectroscopic techniques, in conjunction with textural analysis on generated parametric images, to the histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports.
次要结局
- Correlating the results of ultrasound-based breast cancer characterization to clinical outcomes.(Up to 5 years)
研究者
Dr. Gregory Czarnota
Radiation Oncologist and Clinician Scientist
Sunnybrook Health Sciences Centre