Diagnostic Performance of Contrast-Enhanced Mammography in Suspicious Breast Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- lesion biopsy rate
研究概览
简要总结
Contrast-Enhanced Mammography (CEM) is a functional breast imaging technology. Like magnetic resonance imaging (MRI), CEM neovascularization enhancement can improve cancer detection rates, while lack of enhancement may lead to benign determination. The advantages of CEM are dramatically apparent in women with dense breasts. The purpose of this study was to investigate the additional diagnostic value of CEM added to the standard practice of mammography plus ultrasonography(US) in patients with suspicious breast lesions.
This study was a single-center prospective-retrospective combined observational study. In the prospective part, women with suspected breast abnormalities undergo prospective CEM evaluation, including acquisition of low energy (LE) images and recombined images (RI) showing enhancement, concurrently with breast US. The retrospective part selected the mammography and breast US data of female patients with suspected breast abnormalities who had previous baseline matching.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast ultrasound or/and general mammography suggest that the lesion is BI-RADS 4 or above;
- •Willing to undergo enhanced mammography examination;
- •Agree to perform tumor core needle biopsy or excisional biopsy to confirm pathological diagnosis when necessary.
排除标准
- •Allergy to iodinated contrast;
- •Pregnant and lactating women;
- •Suffering from kidney disease or abnormal kidney function, or undergoing renal dialysis;
- •The breast is too large to be completely included in the full-field mammography examination at one time; ○5 Those with breast implants.
结局指标
主要结局
lesion biopsy rate
时间窗: 2 years
Total biopsy rate (including core needle biopsy and lesion excision biopsy) in patients with BI-RADS 4 and above with and without CEM.
breast cancer detection rate
时间窗: 2 years
Proportion of breast cancer detected among all patients undergoing biopsy.
次要结局
- number of BI-RADS score upgrade(3 years)
研究者
ZHOU Yidong
Breast Surgery Director
Peking Union Medical College Hospital