Abstract
ObjectiveThis study aimed to explore the value of elasticity score (ES) and strain ratio (SR) combined with conventional ultrasound in distinguishing benign and malignant breast masses and reducing biopsy of BI-RADS (Breast Imaging Reporting and Data System) 4a lesions.MethodsThis prospective, multicenter study included 910 patients from nine different hospitals. The acquisition and analysis of conventional ultrasound and strain elastography (SE) were obtained by radiologists with more than 5 years of experience in breast ultrasound imaging. The diagnostic sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under curve (AUC) of conventional ultrasound alone and combined tests with ES and/or SR were calculated and compared.ResultsThe optimal cutoff value of SR for differentiating benign from malignant masses was 2.27, with a sensitivity of 60.2% and a specificity of 84.8%. When combined with ES and SR, the AUC of the new BI-RADS classification increased from 0.733 to 0.824 (p < 0.001); the specificity increased from 48.1% to 68.5% (p < 0.001) without a decrease in the sensitivity (98.5% vs. 96.4%, p = 0.065); and the PPV increased from 52.2% to 63.7% (p < 0.001) without a loss in the NPV (98.2% vs. 97.1%, p = 0.327). All three combinations of conventional ultrasound, ES, and SR could reduce the biopsy rate of category 4a lesions without reducing the malignant rate of biopsy (from 100% to 68.3%, 34.9%, and 50.4%, respectively, all p < 0.001).ConclusionsSE can be used as a useful and non-invasive additional method to improve the diagnostic performance of conventional ultrasound by increasing AUC and specificity and reducing the unnecessary biopsy of BI-RADS 4a lesions.
Highlights
The morbidity of breast cancer is the highest in the world, and the mortality ranks fifth among all cancers but first in female cancers [1]
The lack of specificity of B-mode ultrasound in the diagnosis of breast masses leads to unnecessary biopsy [2], which leads to negative effects such as pain, anxiety, and complications [3]
When combined with elasticity score (ES) and strain ratio (SR), the diagnostic performance of the re-assessed Breast Imaging Reporting and Data System (BI-RADS) classification was as follows: the area under the curve (AUC) increased from 0.733 to 0.824 (p < 0.001); the specificity increased from 48.1% to 68.5% (p < 0.001) without a decrease in the sensitivity (98.5% vs. 96.4%, p = 0.065), and the positive predictive value (PPV) increased from 52.2% to 63.7% (p < 0.001) without a loss in the negative predictive value (NPV) (98.2% vs. 97.1%, p = 0.327, Table 5)
Summary
The morbidity of breast cancer is the highest in the world, and the mortality ranks fifth among all cancers but first in female cancers [1]. The lack of specificity of B-mode ultrasound in the diagnosis of breast masses leads to unnecessary biopsy [2], which leads to negative effects such as pain, anxiety, and complications [3]. Differentiating benign and malignant breast masses and upgrading or downgrading the Breast Imaging Reporting and Data System (BI-RADS) classification to avoid unnecessary biopsy are clinical indications for elastography according to the WFUMB guidelines and recommendations for clinical use of ultrasound elastography to breast [6]. Ultrasound elastography technique may improve the specificity of B-mode ultrasound in the differential diagnosis of breast masses by measuring tissue stiffness [2, 7], even for breast masses smaller than 1 cm in diameter [8]. The combination of conventional ultrasound and SE can reduce unnecessary biopsy of breast masses by down-staging the BIRADS classification [10]. Three diagnostic methods of SE including elasticity score (ES), strain ratio (SR), and strain size ratio (EI/B ratio) were mainly used to classify breast lesions in clinic [6]
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