3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.
研究概览
简要总结
The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.
详细描述
To evaluate the proportions of correct diagnosis of response to breast Cancer therapies for localized breast cancer by ultrasound. To develop a model based on patient characteristics, physical exam, and radiologic studies which will predict the possibility that a patient has had a complete pathological response to chemotherapy neoadjuvant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed breast cancer prior to receiving breast cancer therapy.
- •Diagnosis of breast cancer must be confirmed by fine needle aspiration or core biopsy.
排除标准
- •Poorly controlled diabetes.
- •Contralateral mastectomy prior to neoadjuvant chemotherapy.
- •Not a surgical candidate.
- •No previous axillary lymph node dissection.
研究组 & 干预措施
Healthy Subjects
Ultrasound scan
干预措施: Ultrasound Scan (Procedure)
Cancer
120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan
干预措施: Mammography and Ultrasound (Procedure)
结局指标
主要结局
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.
时间窗: 2002-2014
Self explanatory.
次要结局
- Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor.(2002-2014)
研究者
Paul L. Carson Ph.D
Principal Investigator
University of Michigan