Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,681
- 试验地点
- 16
- 主要终点
- Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
研究概览
简要总结
Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients who have been referred to a breast ultrasound because of a positive physical palpation and/or positive mammograms and/or positive ultrasound and/or positive MRI.
- •age 21 or older
- •provide informed consent
排除标准
- •Women who are unwilling or unable to provide informed consent
- •Women with breast implants
- •Women with superficial lesions or lesions on skin (with the most superficial surface of the lesion within 5 mm of the skin surface)
- •Women who are pregnant or breastfeeding
- •Women who are undergoing chemotherapy or radiotherapy for any cancer
- •Women with previous breast conserving surgery on the breast of interest Note: Previous excision of a benign lesion 4 cm or more away from the suspected lesion does not constitute an exclusion criterion.
结局指标
主要结局
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
时间窗: 2 years
Positive reference standard = malignant cytologic or histopathologic result. Negative reference standard = BIRADS 2 lesions, BIRADS 3 lesions with benign histopathology, or a 1 year follow-up ultrasound exam showing resolved or decreased lesion size. Conservative strategy:features of E-homogeneity, E-max and E-color were used to upgrade BIRADS 3 lesions to BIRADS 4a' or downgrade BIRADS 4a lesions to BIRADS 3'. Aggressive strategy used the same features but upgraded and downgraded more lesions. Based on 939 lesions.
次要结局
- Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature(performed on the same day, within 2 years from study start date)
- Intraobserver Reliability of Quantitative SWE Measurements(performed on the same day, within 2 years from study start date)
- Interobserver Agreement of B Mode Ultrasound and SWE Features(performed on the same day, after study completion)