Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography for Supplemental Breast Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 487
- 试验地点
- 1
- 主要终点
- The number of cancers and false positive findings identified on a CEDM and WBUS as a measure of sensitivity and specificity.
研究概览
简要总结
Breast tumors are often detected on mammography but may be harder to see in women with dense breasts. This is why screening breast ultrasound is sometimes used as another test in women with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen on regular mammography.
Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is essentially a routine digital mammogram performed after iodine dye (the same that is used with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this study is to compare whether CEDM or screening breast ultrasound is better at detecting cancer. Both will be done in this study and compared to one another.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other
- •Women scheduled for screening CEDM alone
- •Women scheduled for WBUS and screening CEDM on the same day or within 30 days of one another
排除标准
- •Age < 30 years old
- •Male patients
- •Patients with any clinical breast symptoms (palpable mass, nipple discharge, etc)
- •Patients with known diagnosis of breast cancer
- •Patients with any breast surgery or biopsy within 90 days prior to the study
- •Patients who have had a lumpectomy for breast cancer within 18 months prior to the study
- •Patients who are thought to have a breast MRI within 1 year prior to the study
- •Patients with contraindication to the intravenous use of iodinated contrast agent (i.e. allergy to iodinated contrast or severely impaired renal function with a creatinine level ≥1.3)
结局指标
主要结局
The number of cancers and false positive findings identified on a CEDM and WBUS as a measure of sensitivity and specificity.
时间窗: 1 year
With respect to imaging, a positive test is defined by a recommendation for biopsy (BIRADS 4 or 5). Negative imaging tests are those with BIRADS 1-3. The number of recommendations for short term follow up (BI-RADS 3) will also be recorded.
次要结局
未报告次要终点