Breast cancer is the most common malignancy among women globally, surpassing lung cancer as the leading cause of cancer incidence in 2022. In India, it is the second most common cancer in women. Early detection through screening is crucial for reducing mortality and improving treatment outcomes.[2].

Multiple modalities are employed in the detection and evaluation of breast lesions, including clinical examination, ultrasonography (USG), mammography (MMG), magnetic resonance imaging (MRI), nuclear isotope scans, and histopathological biopsy [3]. Among these, breast ultrasound is an indispensable diagnostic tool, particularly in symptomatic women, due to its non-invasive nature and ability to characterize lesions with high spatial resolution.

However, conventional ultrasound is limited by relatively high false-positive rates and low positive predictive value, which may lead to unnecessary biopsies and increased patient anxiety [4]. To improve diagnostic confidence, ultrasound elastography—a technique that evaluates tissue stiffnesshas been integrated into routine breast imaging. This method leverages the principle that malignant lesions, due to desmoplastic reactions and increased rigidity, demonstrate reduced deformation under compression, thus appearing stiffer compared to benign lesions [5].

Strain elastography, a form of elastography used in this study, involves applying manual or respiratory-induced compression, allowing for semi-quantitative assessment of tissue strain based on axial displacement with depth [6]. By enhancing the specificity and sensitivity of conventional ultrasound, strain elastography holds the potential to reduce false positives and avoid unnecessary invasive procedures.

This study aims to evaluate the diagnostic utility of strain elastography in the assessment of palpable breast lesions. Specifically, it seeks to classify lesions using the BI-RADS grading system on sonography and compare the diagnostic performance of combined sonographic and elastographic assessment with histopathological findings.

Study Design An observation cross-sectional studyto differentiate between benign and malignant breast lesions using USG elastography, tocharacterize various Breast Lesions and to compare the results of B-Mode ultrasound and Strain Elastography with Histopathological findings [wherever possible].

Study Setting and Duration This is a tertiary care teaching hospital-based study done in Department of Radio-diagnosis, M.G.M. Medical College and M.Y. Hospital and Cancer Hospital, Indore, Madhya Pradesh (MP) for a duration of one year (November 2023- November 2024)

Study Population All patients (≥18 years) referred to Department of Radiodiagnosis with complaints of palpable breast lump in duration of one year. Patients who provided informed consent were included. (Sample size 77)

Inclusion Criteria

1. Cases clinically suspicious of breast lumps of age 18 years and above.
2. Patients with symptoms related to the breast such as Breast lumps, mastalgia, nipple discharge, nipple retraction
3. Breast masses more than 5mm in size [sonologically]

Exclusion Criteria

1. Lesions in post-operative breast.
2. Lesions in post-radiation breast.
3. Recurrence Cases.
4. Pregnant and lactating females.
5. Breast Implant.
6. Patient with genetic disorder.

Sampling Technique Simple random sampling was employed to select the study participants.

Data Collection Procedure& Study Protocol An informed consent was taken from all participants to perform ultrasound and elastography. Clinically relevant personal and family history was taken from every participant. Both ultrasound and elastography was conducted in the same sitting and was performed by same observer.The results were compared with the Histopathological diagnosis to determine the diagnostic accuracy of USG Elastography in characterization of breast lesions.

Ultrasound Examination were performed by a high frequency linear array transducer with a frequency ranging from 7-13 MHz. The lesion’s characteristics assessed based on Breast Imaging Reporting and Data System (BI-RADS) categories outlined by the American College of Radiology (ACR).

Strain elastography was performed in a split screen format with conventional B-mode images displayed on the left and corresponding elastographic colour scale images on the right, allowing simultaneous visualization of both datasets. A color-coded mapping system, where stiffer regions appeared blue, while more deformable areas were depicted in red and green, representing intermediate elasticity; Tsukuba Elasticity Score was used^[7] , which ranges from 1 to 5. In this system, scores of 1–3 are indicative of benign lesions, while scores of 4–5 suggest malignancy. The strain ratio was determined by comparing the average strain within the lesion to that of the surrounding fatty tissue.Based on a study by Deniz Özel et al. ^[8] a cut-off value of 3.1 was taken. The E:B ratio (Elastography-to-B-mode Ratio) was assessed by comparing the lesion’s size on the elastogram to its dimensions on B-mode ultrasound images, providing insight into tissue stiffness. An E:B ratio below 1 was interpreted as benign, whereas a higher ratio was suggestive of malignancy.

Figure 1.   Strain Elastography Tsukuba Elasticity Score ^[7]

Data Analysis

Data were organized and recorded using Microsoft Excel for subsequent analysis. The data were visually represented through various tables and charts. Statistical analysis was performed using SPSS software. Mean values and standard deviations were calculated for quantitative variables. Appropriate statistical tests were applied to evaluate changes in clinical and radiological parameters as needed throughout the study.

Ethical Considerations The study was conducted following ethical standards. Written informed consent was obtained from all participants before their enrollment in the study.

Table 1: Age-wise Distribution of Patients

Maximum number of patients belongs to age group of 18-30 year. 22 number of cases out of 77 patients (28.5%) were found in 18-30 years of age group, similarly, 15 cases (19.4%) were found in 31-40 years of age group, 18 (23.3%) cases were found in 41-50 age group, 13 cases (16.8%) belong to 51-60 years and 9 cases (11.6%) belong to >60 years age group.

Distribution of cases based on clinical features at the time of presentation revealed that the most frequent clinical symptom was a breast lump, reported in 55/77 (71%) cases followed by mastalgia (65%) & nipple retraction (19.4%). A significant number of patients presented with combination of symptoms.

Graph 1 – Laterality distribution of cases

Out of 77 patients, 38 (49.3%) patients had lesion on right side, 35(45.4%) patients had lesion on left side and 4 patients had lesion on both sides.

Graph 2 – Quadrant wise distribution of cases

The quadrant wise distribution of breast lesions, revealed that in 38(49.35%) out of 77 women the breast lesions were located in the upper outer quadrant. This indicates that the UOQ is the most common site for breast lesions in this study population.Most of the women with breast lesions had well defined (42.8%) margins followed by Spiculated margins (37.6%) in the this study.

Graph 3 – USG B-mode characteristics distribution of cases

Graph 4 – USG B-mode characteristics distribution of cases

In 45(58.5%) women, irregular shape & nonparallel orientation is seen on USG B-mode scanning most commonly in this study. Out of 77 patients,36 patients (46.7%) showed Combined posterior acoustic features followed by posterior acoustic shadowing in 33 patients (42.8%). Total of 40 patients (52%) showed Heterogeneous echogenicity followed by Hypoechoic echogenicity in 22 patients (29%). 

Table 2 - Comparison of USG B-mode with Histopathology

Out of total 77 cases, on basis of ultrasound BI-RADS categories, 43 (55.8%) cases showed features of malignant lesion. On histopathology correlation on these 43 cases, 40 cases were found out to be malignant and 3 cases were found to be benign.

Table 3 - Comparison of Elastography Score with Histopathology

Table 4 - Comparison of Strain Ratio & E/B ratio with Histopathology

On Breast strain elastography correlation with histopathology shows that out of 77 cases on basis of elastography Tsukuba score, strain ratio, E/B ratio 46 (59.7%) had features of malignancy. Biopsy was done in all these 46 cases, 44 cases were found to be malignant, and 2 cases were found to be benign on histopathology. Further31 (40.3%) cases showed benign features, on histopathology correlation 30 cases were benign and 1 case were malignant.

The diagnostic performance showed 95.6% Sensitivity, 96.7% Specificity:, 96.1% Accuracy.

Figure 2:- USG images of one of the cases - A 21 yr female patient presented with complaints of left breast lump since 2-3 years. a) Breast USG shows a well-defined oval hypoechoic lesion with combined posterior acoustic features, parallel orientation in left breast -BIRADS III. b) Strain Elastography shows  –Tsukuba Score 3. c) Strain ratio – 2.23 d) E:B ratio – <1 . On Histopathological correlation it was Fibroadenoma.

Figure 3: - USG images of one of the cases - A 53 yr female patient presented with complaints of left breast lump since 5months. a) Breast USG shows a irregular heterogeneously hypoechoic lesion with spiculated margins, posterior acoustic shadowing, non-parallel orientation with internal calcifications with minimal vascularity and ipsilateral axillary lymphadenopathy in right breast b) Strain Elastography shows –Tsukuba Score 5. c) Strain ratio – 7.36 d) E:B ratio – >1. On Histopathological correlation it was Infiltrating ductal carcinoma Grade III.

This study highlights the impact of this newer, simple, effective, non-invasive imaging technique that can be used as a compliment along with ultrasound examination of breast for early detection and treatment of breast lesions, improves the overall quality of life of the patients with breast cancer.

In this study the predominance of younger patients (47.9% under 40 years) suggests a regional or demographic trend where breast lesions are more prevalent in younger women, possibly due to hormonal influences. Similar results were obtained in the study done by Lee et al. (2013)^[9] where  mean age was 46 +13 years.

In this study, Laterality distribution of the 77 cases indicating a near-equal distribution between right and left sides with minimal bilateral cases. This lack of laterality bias aligns with the anatomical and physiological symmetry of breast tissue, where risk factors (e.g., hormonal, genetic, or environmental) are likely to affect both sides equally. Similar study by H. Zhao et al. (2014–2015, China) ^[10], conducted at Fudan University Shanghai Cancer Centre with 276 women, noted no significant laterality bias, with lesions distributed across both breasts.

In this study, the quadrant wise distribution of breast lesions, revealed that in 38(49.35%) out of 77 women the breast lesions were located in the upper outer quadrant. The UOQ’s predominance as the lesion site is likely due to its greater volume of breast tissue and higher density of ductal and lobular structures, which are prone to developing lesions. The study findings were aligning with authentic similar study by Aljarrah and Miller (2014) ^[11]

In this study, on evaluating 77 patients with breast lesions using ultrasound (USG) B-mode scanning, showed that majority of lesions (58.5%, 45/77) exhibited an irregular shape with non-parallel orientation. This is a common feature associated with malignant breast lesions, as irregular shapes and non-parallel orientations often indicate invasive growth patterns. There were approximately 46.7% (36/77) of lesions showed combined posterior acoustic features, while 42.8% (33/77) demonstrated posterior acoustic shadowing. These findings were similar to study by Paulinelli et al. (2017) ^[12] , which reported irregular shape in 68% and posterior shadowing in 50% of 125 malignant lesions among 320 cases, with vascularity (52%), calcifications (45%), and lymphadenopathy (35%) in malignant cases.

In this study , ultrasound findings (USG) using BI-RADS categories were compared to histopathological examination (HPE) in 77 patients with breast lesions. Of the 77 cases, 43 (55.8%) were classified as malignant (BI-RADS 4a, 4b, 4c, 5), with 40 confirmed malignant and 3 benign on HPE. Conversely, 34 (44.1%) cases were classified as benign on USG (BI-RADS 1, 2, 3), with 29 confirmed benign and 5 malignant on HPE.The findings were similar to a study by Lee et al.(2019) ^[13] with  sensitivity, specificity, and accuracy were 91.4%, 88.6%, and 90.5%, respectively similar to this study.

In this study, 77 cases evaluated by breast strain elastography, 46 cases (59.7%) exhibited malignant features based on Tsukuba score, strain ratio, and E/B ratio. Biopsy of these 46 cases confirmed malignancy in 44 cases, with 2 cases being benign on histopathology. Additionally, 31 cases (40.3%) showed benign features on elastography, with histopathology confirming 30 cases as benign and 1 case as malignant. Malignant breast lesions, such as invasive ductal carcinoma (IDC), are typically stiffer due to desmoplastic reactions, increased cellularity, and fibrosis, which result in higher elastography strain ratio(>3.1). In contrast, benign lesions like fibroadenomas are softer, with encapsulated, less dense tissue, leading lower elastography strain ratio (<3.1) Similar study by Ciurea et al. (2011)^[14] including 58 patients; {strain ratio cut-off >3.67} showed Sensitivity: 93.3%, Specificity: 92.9% aligning with this study.

In this study, comparing USG B-mode findings with USG strain Elastography and correlating them with Histopathological diagnosis showed that there is superior diagnostic performance of strain elastography (sensitivity 95.6%, specificity 96.7%, accuracy 96.1%) over conventional ultrasound (sensitivity 93.02%, specificity 85.2%, accuracy 89.6%) in differentiating breast lesions. Elastography’s higher specificity reduces false positives, minimizing unnecessary biopsies, The p-value (<0.0001) for elastography metrics confirms that there is strong correlation with HPE, driven by malignant lesions’ increased stiffness (higher strain ratio, E/B ratio, and Tsukuba scores). The findings of Sinha et al. (2020) ^[15] closely align with the above results with Sensitivity of 90.9% Specificity of 83.9% and Accuracy of 87% with USG B-mode and Sensitivity of 93.2%, Specificity of 94.6% and Accuracy of 94% with Strain elastography confirming that strain elastography (Tsukuba score, strain ratio) outperforms conventional ultrasound in differentiating benign from malignant breast lesions.

Elastography’s superior performance stems from its ability to assess tissue stiffness, a biomechanical property that differentiates malignant (stiffer) from benign (softer) lesions more accurately when combined along with B-mode’s morphological features. 

Our study not only deepens our understanding of the integral connection between non-invasive ultrasound strain elastography in characterization of Breast lesions improving the diagnostic performance when combined with conventional breast ultrasound and reducing rates of unnecessary core biopsy rates but also underscores the potential of this imaging technique to revolutionize patient care in terms of early detection and treatment of Breast lesions with utmost diagnostic accuracy . As the medical landscape continues to evolve, the understanding gained from this study paves the way for improved patient’s diagnosis with confidence, optimized resource utilization, and ultimately, a higher quality of life.

1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71:209–249.
2. Anderson BO, Jakesz R. Breast cancer issues in developing countries: an overview of the Breast Health Global Initiative. World J Surg. 2008;32:2578-85
3. Yamakanamardi S, Hiremath BV. Accuracy of mammography and sonomammography and its correlation with histopathology in the detection of breast cancer. Int Surg J 2021;8:624-30
4. Baker R, Rogers KD, Shepherd N, Stone N. New relationships between breast microcalcifications and cancer. Br J Cancer. 2010;103(7):1034-1039. doi:10.1038/sj.bjc.6605873
5. Berg WA, Bandos AI, Mendelson EB, Lehrer D, Jong RA, Pisano ED. Ultrasound as the Primary Screening Test for Breast Cancer: Analysis From ACRIN 6666. J Natl Cancer Inst. 2015;108(4):djv367.Published doi:10.1093/jnci/djv367
6. Goddi A, Bonardi M, Alessi S. Breast elastography: A literature review. J Ultrasound. 2012 ; 15 (3) : 192 - 198. doi:10. 1016/j. jus.2012. 06. 009
7. Itoh A, Ueno E, Tohno E, Kamma H, Takahashi H, Shiina T, et al. Breast disease: clinical application of US elastography for diagnosis. Radiology 2006;239:341-50.
8. Özel D, Özel BD. Evaluating the role of strain ratio elastography in determining malignancy potential and calculating objective BIRADS US scores using ultrasonography and elastography features. Pol J Radiol. 2018;83:e268-e274. Published 2018 Jun 8. doi:10.5114/pjr.2018.76790
9. Lee et al. (2013) Lee, B. E., Kim, S. H., Choi, H. Y., Park, S. H., & Moon, W. K. (2013). Role of ultrasound and strain elastography in the evaluation of breast masses: Correlation with histopathology. Journal of Ultrasound in Medicine, 32(5), 779–786. doi:10.7863/ultra.32.5.779
10. Zhao et al. (2014–2015) Zhao, H., Gong, X., & Xu, H. (2015). Laterality distribution of breast lesions: A retrospective analysis of 276 cases. Chinese Journal of Cancer Research, 27(3), 295–300.
11. Aljarrah and Miller (2014) Aljarrah, A., & Miller, W. R. (2014). Distribution of breast lesions in the upper outer quadrant: A retrospective analysis. Breast Cancer Research and Treatment, 145(2), 511–517. doi:10.1007/s10549-014-2968-9
12. Paulinelli et al. (2017) Paulinelli, R. R., de Freitas-Junior, R., & Soares, L. R. (2017). Ultrasound characteristics of breast lesions: Association with histopathological findings. Radiologia Brasileira, 50(3), 151–158. doi:10.1590/0100-3984.2016.0068
13. Lee et al. (2019) Lee, S. H., Moon, W. K., & Cho, N. (2019). Diagnostic performance of ultrasound in breast lesion characterization: A multicenter study. American Journal of Roentgenology, 212(4), 934–942. doi:10.2214/AJR.18.20507
14. Ciurea et al. (2011) Ciurea, A. I., Bolboaca, S. D., Ciortea, C. A., & Dudea, S. M. (2011). The role of strain ratio in breast ultrasound elastography: Preliminary results. Medical Ultrasonography, 13(3), 197–204.
15. Sinha et al. (2020) Sinha, A., Gupta, R., & Singh, S. (2020). Diagnostic accuracy of strain elastography versus conventional ultrasound in breast lesions: A comparative study. Journal of Medical Ultrasound, 28(2), 108–114.