Worldwide, breast lesions are a major clinical issue due to the high incidence of breast cancer, which is a major cause of death and disability among women. Timely diagnosis, adequate treatment, and improved patient outcomes depend on early and accurate classification between benign and malignant breast lesions [1]. Mammography and B-mode ultrasonography are two of the most common conventional imaging modalities used to assess breast masses; however, these methods may not always reliably differentiate between benign and malignant lesions, which might result in needless biopsies or diagnostic delays [2, 3].

Due to increased cellular density, fibrosis, and desmoplastic response, malignant tissues tend to be stiffer than benign tissues. An developing imaging tool that assesses tissue stiffness based on this idea is ultrasound elastography. It evaluates the mechanical characteristics of tissues in real time, adding functional information to traditional ultrasound. There has been encouraging progress in improving diagnostic accuracy using various elastographic approaches, such as strain elastography and shear wave elastography [4-6].

The use of ultrasound elastography to evaluate breast lesions has grown in popularity in recent years due to its lack of invasiveness, low cost, and reproducibility. As a result, lesion definition is improved, and less invasive treatments like core needle biopsy and fine-needle aspiration cytology may be required. The absence of defined grading methods and the potential for subjective interpretation are still obstacles, notwithstanding the benefits [7-9].

The most reliable method for confirming the diagnosis of breast lesions is histopathological analysis. Thus, in order to confirm the clinical value of elastography, it is essential to correlate its results with histology. The purpose of this research is to compare the diagnostic performance of ultrasonic elastography to that of histological methods in identifying benign from malignant breast lesions [10, 11].

This prospective observational study was conducted at the Department of Pathology, S.S. Institute of Medical Sciences, Davangere, Karnataka, between November 2021 to October 2022. The study was carried out in collaboration with the Department of Radiodiagnosis. A total of 40 patients presenting with clinically palpable or radiologically detected breast lesions were included after obtaining informed consent. Ethical clearance was obtained from the Institutional Ethics Committee prior to the commencement of the study. Procedure: All patients underwent detailed clinical evaluation followed by conventional B-mode ultrasonography of the breast using a high-frequency linear transducer. Subsequently, ultrasound elastography was performed on the identified lesions. Strain elastography technique was used to assess tissue stiffness, and elasticity scores were assigned based on standard scoring systems (such as the Tsukuba scoring system). The strain ratio between the lesion and adjacent normal tissue was also calculated where applicable. Following imaging, all patients underwent histopathological evaluation through either fine-needle aspiration cytology (FNAC), core needle biopsy, or excisional biopsy, depending on clinical indications. The elastographic findings were then compared with histopathological results, which served as the gold standard for diagnosis. Inclusion Criteria: • Patients aged 18 years and above presenting with breast lumps. • Patients with sonographically detectable breast lesions. • Patients willing to undergo elastography and histopathological evaluation. Exclusion Criteria: • Patients with prior breast surgery or radiotherapy. • Patients with cystic lesions lacking solid components. • Pregnant women where imaging limitations existed. • Patients unwilling or unfit for biopsy procedures. Statistical Analysis: Data were entered and analyzed using appropriate statistical software. Diagnostic performance of ultrasound elastography was evaluated by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy. Chi-square test was used to assess the association between elastographic findings and histopathological results. A p-value of less than 0.05 was considered statistically significant.

A total of 40 patients with breast lesions were evaluated using ultrasound elastography and correlated with histopathological findings.

Table 1: Age Distribution of Patients

Patients between the ages of 18 and 30 made for 25% of the total, with those between the ages of 31 and 40 accounting for 30%. The study found that breast lesions were more common in middle-aged and older women, as 45% of the patients were over the age of 40.

Table 2: Distribution of Benign and Malignant Lesions (Histopathology)

Sixty percent of the lesions were benign, according to the histopathology report, while forty percent were cancerous. The majority of the lesions in the study population were considered benign.

Table 3: Elastography Score Distribution

The majority of benign lesions (75%) exhibited softer tissue consistency, as indicated by lower elastography values (1-2). The bulk of malignant lesions, on the other hand, showed greater stiffness with higher scores (4-5). Based on elastographic scoring, benign lesions can be easily distinguished from malignant ones.

Table 4: Correlation between Elastography and Histopathology

The results of the ultrasound elastography confirmed the presence of 21 benign and 15 malignant lesions. Three false positives and one false negative were detected. This suggests that histological diagnosis and elastography results are highly correlated.

Table 5: Diagnostic Performance of Ultrasound Elastography

In distinguishing between benign and malignant lesions, ultrasound elastography showed a high level of sensitivity (93.75%) and specificity (87.50%). Elastography seems to be quite good in ruling out cancer, according to the high NPV (95.45%). Elastography has shown to be a dependable diagnostic tool, with an overall accuracy rate of 90%.

This study assessed the efficacy of ultrasonic elastography in distinguishing between benign and malignant breast lesions, using histology as the gold standard. The precise characterisation of breast lesions is essential for early detection and effective care, with elastography serving as a significant complement to traditional imaging techniques [12].

The current study found that most patients were aged 31–40, aligning with prior research indicating that benign breast lesions are more prevalent in younger women, whereas malignancies are more frequently reported in older demographics. The histological distribution in this investigation indicated that 60% of lesions were benign and 40% were malignant, aligning with trends documented in previous literature [13, 14].

The current investigation revealed that elastography score effectively differentiated between benign and malignant tumors. Benign lesions typically displayed lower elasticity values (1–2), signifying softer tissue consistency, while malignant lesions generally demonstrated higher scores (4–5), suggesting greater stiffness. Previous research have revealed analogous findings, indicating that malignant tissues exhibit greater stiffness attributed to heightened cellularity, fibrosis, and desmoplastic response [15-17].

The diagnostic performance in this investigation shown great sensitivity (93.75%) and specificity (87.50%), closely aligning with prior research on ultrasonic elastography. The significant negative predictive value (95.45%) identified in this study indicates that elastography is especially effective in excluding malignancy, hence potentially minimizing unnecessary invasive interventions like biopsies. The current investigation revealed a robust association between elastography findings and histological results, with minimal instances of false positives and false negatives. Previous investigations have revealed such relationships, reinforcing the reliability of elastography as a diagnostic instrument [18-20].

Nonetheless, specific limitations were identified in the current investigation. Certain benign lesions, especially those containing fibrous elements, may exhibit rigidity on elastography, thereby resembling malignancy and resulting in false-positive outcomes. In contrast, specific malignant tumors featuring necrotic or cystic regions may exhibit a softer consistency, leading to false negatives. Furthermore, operator dependency and the absence of established methods may affect the reproducibility of elastography results. Previous research have also emphasized these limitations [21-23].

Notwithstanding these constraints, the results of the current investigation endorse the application of ultrasound elastography as a non-invasive, economical, and dependable imaging technique. When integrated with traditional ultrasonography, it augments diagnostic certainty and facilitates improved clinical decision-making. Additional extensive investigations are advised to corroborate these findings and to formulate standardized protocols for the regular application of elastography in assessing breast lesions [24, 25].

This study shows that ultrasound elastography is a valid and effective imaging method for distinguishing benign and malignant breast lesions. It had great sensitivity, specificity, and diagnostic accuracy when compared to histological results, the gold standard. Elastography's tissue stiffness assessment improves lesion characterisation and diagnostic confidence beyond ultrasonography. Its significant negative predictive value helps rule out malignancy, decreasing biopsies. Interpreting data requires consideration of operator dependency and stiffness overlap between benign and malignant lesions. Ultrasound elastography improves diagnostic performance when utilized with conventional imaging, despite these obstacles. Ultrasound elastography is non-invasive, cost-effective, and useful for routine breast lesion evaluation. Standardizing methods and validating clinical use require larger investigations. Funding None Conflict of Interest: None

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