Comparison of Preoperative Automated Breast Ultrasound (ABUS) and Magnetic Resonance Imaging (MRI) in Newly Diagnosed Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging
研究概览
简要总结
Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging (MRI) in Newly Diagnosed Breast Cancer Patients.
详细描述
This is a prospective pilot study investigating the use of Automated Breast Ultrasound in the preoperative evaluation of newly diagnosed breast cancer patients. The Investigator intends to demonstrate that preoperative automated breast ultrasound (ABUS) will provide a relatively inexpensive and well-tolerated alternative to MRI for detection of occult breast cancer missed by mammography and hand-held ultrasound in women with newly diagnosed breast cancer. The research will take place at the University of Kansas Medical Center (KUMC). The research study will be open to newly diagnosed breast cancer patients who present to KUMC with a recommendation for preoperative MRI and who fit all inclusion criteria and have none of the exclusion criteria.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women (age 18-100) undergoing preoperative evaluation at the University of Kansas Cancer Center (KUCC) for a new diagnosis of breast cancer
- •Patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy.
- •Bilateral mammography and hand-held ultrasound (if clinically indicated) performed prior to the MRI and ABUS.
- •If a breast MRI is advised and there is no contraindication to MRI, a breast MRI and ABUS will performed at KUCC (Study Arm 1).
- •If a breast MRI is not performed, an ABUS exam without MRI will be performed (Study Arm 2).
- •The MRI and ABUS exam must be obtained within 2 weeks of each other.
排除标准
- •Pregnant women
- •Lactating women
- •Patients < 18 and > 100 years of age
- •Patients with breast implants
结局指标
主要结局
Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging
时间窗: 1 day
Rate of detection of occult breast cancer by ABUS, otherwise missed by standard imaging (MRI or mammogram with hand-held breast ultrasound as clinically indicated).
次要结局
未报告次要终点