European Journal of Cardiovascular Medicine

Breast cancer is one of the most common malignancies among women worldwide. Early and accurate differentiation of benign and malignant breast lesions is critical for effective management and improved survival outcomes. Traditional imaging modalities like mammography and B-mode ultrasonography are the mainstays of initial evaluation, but their sensitivity is limited in dense breast tissue.

Ultrasound elastography (UE), including both strain and shear wave techniques, is a non-invasive imaging method that measures tissue stiffness, a feature often increased in malignancies. Recent studies have shown that malignant lesions are generally stiffer than benign ones, and elastography can improve lesion characterization when combined with grayscale ultrasound.

This study aims to assess the efficacy of ultrasound elastography in differentiating focal breast lesions and to correlate imaging findings with histopathological outcomes

This was a prospective observational study conducted in a tertiary care radiology department over a period of 18 months. A total of 100 female patients presenting with palpable or imaging-detected focal breast lesions were included.

Inclusion Criteria:

• Age > 18 years
• Palpable breast lump or lesion on prior imaging
• Willingness to undergo ultrasound and biopsy

Exclusion Criteria:

• History of breast surgery or trauma
• Pregnancy
• Known systemic illness affecting breast architecture

Imaging Protocol

Each patient underwent:

• B-mode ultrasound using a high-frequency linear probe (7.5–12 MHz)
• Strain elastography (SE) and Shear wave elastography (SWE)

Lesions were evaluated for:

• Size, shape, margin, echotexture
• BI-RADS category
• Elastography scoring (Tsukuba 5-point scale for SE)
• Quantitative strain ratio or shear wave velocity

Reference Standard

All patients underwent either fine-needle aspiration cytology (FNAC) or core biopsy. Histopathological results were used as the gold standard.

Statistical Analysis

Data were analyzed using SPSS version 25. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of elastography were calculated. A p-value < 0.05 was considered statistically significant.

Table 1: Demographic Distribution

This table presents the age distribution of the patients. The highest number of participants (34%) were in the 31–45 year age group, suggesting this demographic has the highest incidence of palpable breast lesions requiring imaging.

Table 2: Histopathological Diagnosis

Among the 100 lesions evaluated, 68 were benign (including fibroadenomas, cysts, and hyperplasia), while 32 were malignant (mostly IDC and ILC). This distribution served as the reference standard for imaging correlation.

Table 3: Elastography Scores

Elastography scores were higher in malignant lesions, with most scoring 4 or 5 on the Tsukuba scale. Benign lesions mostly scored 1 to 3. This indicates a strong correlation between high elastography scores and malignancy.

Table 4: Diagnostic Performance Metrics

Ultrasound elastography demonstrated a high sensitivity (91%) and specificity (85%), yielding a diagnostic accuracy of 88%. These metrics underscore the reliability of elastography as a diagnostic tool when integrated with conventional ultrasound.

Table 5: Master Table with Mean ± SD and p-values

Quantitative parameters such as strain ratio, lesion size, and shear wave velocity were all significantly higher in malignant lesions (p < 0.001). These metrics provide measurable criteria to differentiate benign from malignant lesions in a clinical setting.

Impact on Clinical Management

Table 1: Demographic Distribution

Table 2: Histopathological Diagnosis

Table 3: Elastography Scores

Table 4: Diagnostic Performance Metrics

Table 5: Master Table with Mean ± SD and p-values

In 27 cases, elastography findings led to altered decisions—such as avoiding biopsy in low-score lesions or expediting treatment in high-score ones.

This study demonstrates the significant diagnostic value of ultrasound elastography in evaluating focal breast lesions. Elastography provided a reliable, non-invasive assessment of tissue stiffness, showing strong concordance with histopathological results.

Malignant lesions displayed higher elastography scores and strain ratios, consistent with previous literature by Itoh et al. (1), Barr et al. (2), and Thomas et al. (3). The mean elasticity score difference between benign and malignant lesions was statistically significant (p < 0.001), aligning with the findings by Bojan et al. (4) and Lee et al. (5).

The sensitivity (91%) and specificity (85%) achieved in our study were comparable to or better than values reported in meta-analyses by Berg et al. (6) and Zhang et al. (7). Furthermore, elastography altered clinical decision-making in 27% of patients, reducing unnecessary biopsies—an effect echoed by Cho et al. (8) and Zhi et al. (9).

A limitation of the study includes operator dependency and subjectivity in strain elastography interpretation. Future research could focus on automated quantification and AI-based evaluation to reduce interobserver variability (10).

Ultrasound elastography is a highly effective adjunct to conventional ultrasound in the evaluation of focal breast lesions. Its ability to differentiate benign from malignant tissue based on stiffness can improve diagnostic accuracy and reduce unnecessary interventions. We recommend its inclusion in routine breast imaging protocols.

1. Itoh A, Ueno E, Tohno E, et al. Breast disease: clinical application of US elastography for diagnosis. Radiology. 2006;239(2):341-350.
2. Barr RG. Sonographic breast elastography: a primer. J Ultrasound Med. 2012;31(5):773-783.
3. Thomas A, Fischer T, Frey H, et al. Real-time elastography—an advanced method of ultrasound: first results in 108 patients with breast lesions. Ultrasound Obstet Gynecol. 2006;28(3):335-340.
4. Bojan M, Stoenescu L, Zaharia A, et al. Role of ultrasound elastography in the assessment of breast lesions. Med Ultrason. 2010;12(3):215-220.
5. Lee JH, Kim SH, Kang BJ, et al. Role of shear-wave elastography in the diagnosis of breast lesions: comparison with strain elastography. AJR Am J Roentgenol. 2014;203(2):W199-W206.
6. Berg WA, Cosgrove DO, Doré CJ, et al. Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses. Radiology. 2012;262(2):435-449.
7. Zhang Y, Lv F, Tang J, et al. Clinical value of real-time elastography for the diagnosis of breast lesions: a systematic review and meta-analysis. Ultrasound Med Biol. 2014;40(5):1036-1048.
8. Cho N, Moon WK, Park JS, et al. Nonpalpable breast masses: evaluation by US elastography. Korean J Radiol. 2008;9(2):111-118.
9. Zhi H, Xiao XY, Ou B, et al. Could ultrasonic elastography help the diagnosis of small (≤2 cm) breast cancer with the usage of ultrasonic BI-RADS classification? Eur J Radiol. 2012;81(11):3216-3221.
10. Kim J, Kim EK, Moon HJ, et al. Computer-aided diagnosis using US elastography in the evaluation of breast lesions. Radiology. 2017;285(3):839-847.