Palpable breast lumps are a common clinical presentation and encompass a wide range of benign and malignant disorders. Although many palpable masses are benign, breast cancer remains a major global health problem, making timely and structured assessment important (1).

Breast ultrasonography is an established imaging modality for evaluating palpable breast abnormalities. It can distinguish cystic from solid lesions and provides detailed assessment of lesion morphology, including shape, orientation, margins, echogenicity, posterior acoustic behavior and vascularity (2).

Ultrasound has particular value in younger women and in breasts with dense tissue, and it is commonly used as a targeted examination when a clinically palpable abnormality is present. Current appropriateness guidance

emphasizes age- and presentation-specific imaging pathways for palpable breast masses (3).

The American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) provides standardized terminology and assessment categories for breast imaging. Consistent application of BI-RADS helps communicate the level of suspicion and supports decisions regarding surveillance, additional imaging and tissue diagnosis (4).

Several sonographic features are recognized as suspicious for malignancy, including irregular shape, non-parallel orientation, angular or spiculated margins, posterior acoustic shadowing, internal vascularity and abnormal axillary lymph nodes. Conversely, oval shape, parallel orientation and circumscribed margins are frequently associated with benign masses (5). Breast cancer diagnosis ultimately depends on tissue evaluation when imaging or clinical findings are suspicious. Image-guided core needle biopsy is widely used to establish histological diagnosis before definitive treatment, while radiologic-pathologic concordance remains important in clinical management (6).

Histopathological examination also permits classification of invasive and in-situ disease and provides information that cannot be established reliably by ultrasound alone. Therefore, comparison of imaging findings with histopathology is an important component of evaluating diagnostic performance (7). Standardized breast-imaging terminology and assessment systems have been developed to improve consistency between imaging interpretation and subsequent management (8).

Clinical breast assessment and imaging are complementary, and tissue diagnosis is indicated when imaging findings are suspicious or when clinical and imaging findings are discordant (9). Correlation between imaging appearance and pathological diagnosis is therefore important when evaluating the diagnostic performance of breast ultrasound in patients with palpable masses (10). The present study was conducted to evaluate the correlation between breast ultrasound findings and histopathological diagnoses among patients with palpable breast lumps, with particular emphasis on BI-RADS category and individual sonographic characteristics associated with benign and malignant outcomes.

This cross-sectional study was done at Bacha khan medical complex swabi from October 2024 to March 2025 was based on data from 60 patients presenting with palpable breast lumps who underwent breast ultrasonography and subsequent histopathological evaluation. The dataset included demographic information, clinical characteristics of the palpable lump, ultrasound findings, BI-RADS category and final histopathological diagnosis. All participants in the provided dataset were female.

Patient age, duration of the palpable lump, side of involvement, breast quadrant and maximum lump size were recorded. Ultrasonographic assessment included lesion shape, orientation, margin characteristics, echogenicity, posterior acoustic features, calcification, vascularity and axillary lymph-node status. Ultrasound findings were categorized according to the recorded BI-RADS classification. Histopathological examination was considered the reference standard for final diagnosis. Histopathological diagnoses were subsequently classified into benign or malignant groups for diagnostic analysis.

Continuous variables were summarized as mean ± standard deviation, while categorical variables were presented as frequencies and percentages. Differences in continuous variables between benign and malignant groups were assessed using independent-samples tests. Associations between categorical ultrasound characteristics and histopathological classification were evaluated using chi-square or Fisher's exact tests as appropriate. BI-RADS categories were grouped as BI-RADS 2–3 versus BI-RADS 4–5 for assessment of diagnostic performance. Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy were calculated using histopathology as the reference standard. Agreement between the ultrasound-based classification and histopathological classification was assessed using Cohen's kappa. A p-value <0.05 was considered statistically significant.

Table 1 summarizes the demographic and clinical characteristics of the 60 patients included in the study.

Table 1. Demographic and clinical characteristics of the study population

The mean age of the participants was 44.15 ± 10.55 years, ranging from 26 to 63 years. The mean lump size was 2.16 ± 0.67 cm, while the mean reported duration was 4.93 ± 3.31 months. The right and left breasts were equally represented. The upper outer quadrant was the most frequently involved site, accounting for 28 (46.7%) lesions.

The histopathological distribution of the study population is presented in Table 2.

Table 2. Histopathological diagnoses of palpable breast lumps

Histopathology demonstrated an equal distribution of benign and malignant lesions, with 30 (50.0%) cases in each group. Fibroadenoma was the predominant benign diagnosis, accounting for 25 cases (41.7% of the total study population). Among malignant lesions, invasive ductal carcinoma was the most frequent diagnosis, occurring in 22 (36.7%) patients, followed by invasive lobular carcinoma in 7 (11.7%) patients.

Table 3 compares the clinical and ultrasound characteristics of benign and malignant lesions and demonstrates the major sonographic differences between the two groups.

Table 3. Comparison of clinical and ultrasound characteristics according to histopathological diagnosis

Malignant lesions occurred in significantly older patients and were significantly larger and of longer reported duration than benign lesions. The ultrasound morphology also showed strong associations with histopathological classification. All malignant lesions were irregular, whereas benign lesions were oval or round. Non-parallel orientation was present in 80.0% of malignant lesions compared with none of the benign lesions. Spiculated, angular or indistinct margins were observed among malignant lesions, while almost all benign lesions had circumscribed margins. Posterior acoustic shadowing, internal vascularity and abnormal axillary lymph nodes were also predominantly observed in malignant cases.

The distribution of BI-RADS categories according to histopathology and the corresponding diagnostic-performance measures are presented in Table 4.

Table 4. BI-RADS category and diagnostic performance compared with histopathology

Table 4 (continued). Diagnostic performance of BI-RADS ≥4

There was a clear relationship between BI-RADS classification and histopathological diagnosis. All lesions classified as BI-RADS 2 or 3 were benign, whereas all lesions classified as BI-RADS 4 or 5 were malignant (p<0.001). Using BI-RADS ≥4 as the threshold for malignancy, ultrasound correctly identified all 30 malignant lesions and all 30 benign lesions, producing 100% sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy, with perfect agreement with histopathology (κ=1.00). Spearman correlation between BI-RADS category and malignant histopathology was ρ=0.904, p<0.001.

The present study evaluated the relationship between breast ultrasonography findings and histopathological diagnoses among 60 patients with palpable breast lumps. An equal number of benign and malignant lesions were identified. The findings showed strong associations between several sonographic characteristics and final histopathology.

Patients with malignant lesions were substantially older than those with benign lesions. This age difference is consistent with the broader epidemiology of breast cancer, in which incidence increases with age, although age alone cannot distinguish an individual benign mass from malignancy (11).

Malignant lesions in this dataset were also larger and had a longer reported duration than benign lesions. These findings are clinically plausible, but lesion size and duration should be interpreted together with imaging morphology and clinical context rather than used as independent diagnostic criteria (12).

All malignant lesions in the dataset were irregular, whereas benign lesions were oval or round. This pattern is consistent with established ultrasound descriptors in which irregular shape is a suspicious feature, while oval shape is commonly associated with benign masses (13).

Orientation showed a similarly strong pattern. Most malignant lesions were not parallel to the skin, whereas all benign lesions were parallel. A non-parallel or 'taller-than-wide' orientation is a recognized suspicious sonographic feature and is incorporated into standardized breast ultrasound assessment (14).

Margin characteristics were also strongly associated with histopathology. Benign lesions were predominantly circumscribed, while malignant lesions demonstrated spiculated, angular or indistinct margins. These findings are consistent with the BI-RADS lexicon, in which non-circumscribed margins increase the level of suspicion (15).

Posterior acoustic shadowing was frequent among malignant lesions and absent among benign lesions in the supplied dataset. Although posterior shadowing can be associated with malignancy, it is not specific and should be interpreted together with the complete sonographic appearance (16).

Vascularity also differed between groups. Most benign lesions were avascular, while internal vascularity was common among malignant lesions. Doppler vascularity may provide supportive information, but vascularity alone is not sufficiently specific to replace morphological assessment or tissue diagnosis (17).

Abnormal axillary lymph nodes were identified in 80.0% of malignant cases and in none of the benign cases. Abnormal nodal morphology can increase suspicion for metastatic disease, but axillary findings should be interpreted in the context of the primary breast lesion and, when appropriate, confirmed by tissue sampling (18).

The strongest association in this dataset was observed for BI-RADS category. All BI-RADS 2–3 lesions were benign, while all BI-RADS 4–5 lesions were malignant. BI-RADS is designed to standardize imaging interpretation and management recommendations, and the present findings illustrate the clinical usefulness of structured categorization (19).

The calculated sensitivity, specificity, predictive values and diagnostic accuracy were all 100% when BI-RADS ≥4 was used as the threshold for malignancy. Although these values are mathematically correct for the supplied dataset, they should not be interpreted as evidence that ultrasound universally achieves perfect diagnostic accuracy. Real-world studies generally contain overlapping imaging features, indeterminate lesions and discordant imaging-pathology results (20).

The perfect separation observed in the present data may be partly related to the dataset structure, in which BI-RADS categories 2–3 occur only among benign cases and categories 4–5 only among malignant cases. This creates complete separation and inflates apparent diagnostic performance. External validation using a larger, independently collected cohort would therefore be important before generalizing these estimates (21).

Fibroadenoma was the predominant benign diagnosis, while invasive ductal carcinoma was the predominant malignant diagnosis. This distribution is compatible with the common spectrum of palpable breast lesions encountered in clinical practice, although the proportions in a small selected cohort should not be assumed to represent the prevalence of disease in the wider population.

The findings also reinforce the importance of radiologic-pathologic concordance. Ultrasound can stratify risk and guide biopsy, but histopathology remains necessary for definitive diagnosis of suspicious lesions and for establishing tumor subtype and other pathological characteristics that influence treatment (22).

Current breast-imaging practice increasingly incorporates quantitative ultrasound, elastography and computer-assisted analysis. These approaches may complement conventional morphology, but their clinical value depends on appropriate validation, standardized acquisition and integration with established diagnostic pathways.

Overall, the present dataset demonstrates a strong correlation between ultrasound morphology, BI-RADS category and histopathological outcome. The results support the use of systematic ultrasound assessment for palpable breast lumps while emphasizing that suspicious imaging findings require appropriate tissue diagnosis and that apparently perfect performance in a small dataset should be interpreted cautiously.

Breast ultrasonography demonstrated a strong correlation with histopathological diagnosis among patients with palpable breast lumps in the analyzed dataset. Suspicious sonographic characteristics—including irregular shape, non-parallel orientation, non-circumscribed margins, posterior acoustic shadowing, internal vascularity and abnormal axillary lymph nodes—were predominantly associated with malignant histopathology. BI-RADS categories 4–5 were associated with malignant lesions, while BI-RADS categories 2–3 were associated with benign lesions.

Although perfect diagnostic performance was observed in this dataset, the findings should be interpreted within the limitations of the sample size and dataset composition. Histopathological examination remains essential for definitive diagnosis of suspicious breast lesions.

LIMITATIONS

• The study included only 60 patients, limiting the precision and generalizability of the findings.
• All participants were female, so the results cannot be directly extrapolated to male breast lesions.
• The dataset contains a highly clear separation between BI-RADS categories and histopathological outcomes, resulting in perfect diagnostic performance that may not reflect routine clinical populations.
• The study was based on a cross-sectional dataset, preventing assessment of long-term clinical outcomes.
• Interobserver variability between radiologists was not available.
• Mammographic findings and clinical breast-examination findings were not included.
• Detailed histopathological parameters such as tumor grade, receptor status and molecular subtype were not available.

RECOMMENDATIONS

• Breast ultrasonography should remain an important component of evaluation of palpable breast lumps, particularly when lesion characterization is required.
• BI-RADS should be used systematically to standardize ultrasound reporting and guide further management.
• Suspicious lesions should undergo appropriate tissue sampling for definitive diagnosis.
• Larger prospective studies should evaluate diagnostic performance across a broader spectrum of BI-RADS categories and include discordant imaging–histopathology cases.
• Future studies should incorporate mammography, Doppler parameters, elastography and clinical examination findings to evaluate a multimodal diagnostic approach.

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