Confirmed value of shear wave elastography for ultrasound characterization of breast masses using a conservative approach in Chinese women: a large-size prospective multicenter trial

Xi Lin, Cai Chang, Changjun Wu, Qin Chen, Yulan Peng, Baoming Luo, Lina Tang, Jing Li, Jihui Zheng, Ruhai Zhou, Guanghe Cui, Ao Li, Xuemei Wang, Linxue Qian, Jianxing Zhang, Chaoyang Wen, Joel Gay, Huili Zhang, Anhua Li, Yaling Chen, Xi Lin, Cai Chang, Changjun Wu, Qin Chen, Yulan Peng, Baoming Luo, Lina Tang, Jing Li, Jihui Zheng, Ruhai Zhou, Guanghe Cui, Ao Li, Xuemei Wang, Linxue Qian, Jianxing Zhang, Chaoyang Wen, Joel Gay, Huili Zhang, Anhua Li, Yaling Chen

Abstract

Purpose: This study aimed to investigate the value of shear wave elastography (SWE) for characterization of breast masses in a Chinese population.

Patients and methods: Two thousand two hundred seventy-three women consented to be prospectively enrolled for the characterization of breast masses with ultrasound and SWE. Breast masses were known from symptoms, palpability, and/or previous imaging screening with mammography and/or ultrasound. Correlation of SWE qualitative and quantitative features with malignancy risk and impact on diagnostic performance of combining SWE features were assessed, and the Breast Imaging Reporting and Data System (BI-RADS) scoring was calculated using histopathology as reference.

Results: Data of 2,262 masses (median size: 13 mm; range: 1.3-50) from 2,262 patients (median age: 43 years; range: 18-91) were investigated, of which 752 (33.3%) were malignant. Sensitivity and specificity of BI-RADS diagnosis were 97.5% (733/752) and 54.8% (827/1,510), respectively. By logistic regression, the combination of maximum elasticity (E max) measurements with BI-RADS assessments increased the area under the receiver operating characteristic curve from 0.908 (95% CI: 0.896-0.920) to 0.954 (95% CI: 0.944-0.962). Using E max of 30 kPa or lower to selectively downgrade BI-RADS 4a masses to follow-up, and E max of 160 kPa or higher to selectively upgrade BI-RADS 3 lesions to biopsy, specificity significantly increased from 54.8% (827/1,510) to 66.1% (998/1,510) (P<0.001) while sensitivity decreased nonsignificantly from 97.5% (733/752) to 96.9% (729/752) (P=0.2891). Positive predictive value for biopsy recommendation increased from 51.7% (733/1,417) to 58.7% (729/1,241) (P<0.001).

Conclusion: Adding SWE maximum stiffness to BI-RADS 3 and BI-RADS 4a breast masses in a Chinese population increased significantly the specificity of breast ultrasonography, without significant change in sensitivity.

Keywords: breast cancer; multicenter; shear wave elastography; ultrasound.

Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Seven patterns could be demonstrated on the images acquired in ShearWave™ Elastography (SWE). Notes: (A) No findings: No difference is observed at the margin of or inside the lesion with the color around the lesion (homogeneously blue). (B) Vertical stripes pattern: A color is observed at the margin of or inside the lesion, which differs from the color around the lesion. The differing color extends beyond the lesion and continues vertically in cords on the cutaneous side and/or the thoracic wall. (C) Rim of stiffness pattern: A localized colored area appears at the margin of the lesion and creates a continuous closed circle. (D) Colored lesion pattern: Colored areas are heterogeneously visible inside the lesion. (E) Void center pattern: There is a lack of SWE signal inside the lesion. The rest of the SWE Box fills correctly. (F) Horseshoe pattern: A localized colored area appears at the margin of the lesion and creates an open circle. (G) Spots pattern: Colored areas are visible above and/or below the lesion.
Figure 2
Figure 2
Two-dimensional grayscale ultrasound image (bottom) of a breast lesion in a 51-year-old female patient. Notes: According to morphological signs, the lesion was classified as probably benign (BI-RADS 3). Upper image shows the SWE semitransparent map that overlays the grayscale anatomical image. The largest dotted line circular region of interest (ROI) marked with an “X” was used to quantify global lesion stiffness values, reported on the right-hand side under “XQ-Box™.” The two smallest ROIs were used to calculate the elasticity ratio between the stiffest area within the lesion or surrounding stiffness halo and breast fatty tissue used as a reference. The SWE features of this lesion were suspicious for malignancy. Pathological outcome from breast biopsy was a mixed papillocarcinoma with mixed ductal carcinoma. Abbreviations: BI-RADS, Breast Imaging Reporting and Data System; SWE, shear wave elastography.

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