Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Objective Response
研究概览
简要总结
The purpose of this study is to determine whether four new alternative imaging methods can be used to follow the response of breast cancer to the treatment patients are being given. These methods produce an image of the inside of the breast so that doctors can better decide whether breast cancer is responding to therapy. An important part of the study is to examine the same person with all methods in order to directly compare results. The four methods are: MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy (abbreviated NIR). In addition to the experimental imaging methods, patients may also undergo a contrast-enhanced MRI, and/or additional mammography, which will help researchers compare the experimental methods. These additional examinations are accepted diagnostic procedures; they are not experimental. Some participants will have one or both of these additional examinations if clinically indicated.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Locally advanced breast cancer, with or without metastatic disease
- •Patient to receive systemic therapy
- •Breast size and epithelial integrity adequate to allow alternate imaging exams.
- •Patient able to provide written informed consent.
- •No serious associated psychiatric illness
- •Age ≥ 18 years old
排除标准
- •Cardiac pacemaker
- •Any implanted electronic device
- •Severe claustrophobia
- •Allergy to the MRI contrast agent gadolinium
结局指标
主要结局
Objective Response
时间窗: at baseline, at conclusion of treatment (up to 6 months)
Correlate changes in each imaging modality with objective response to therapy, as defined by conventional criteria (clinical exam and conventional imaging).
次要结局
未报告次要终点
