European Journal of Cardiovascular Medicine

Around a quarter (25%) of all cancer cases in women are breast cancer, making it the most frequent cancer in the world for women. Prior until recently, cervical cancer was the most frequent cancer among Indian women; however, the primary cause of cancer-related mortality is breast cancer, which is currently more common than cervical cancer. In rural India, cervical cancer is still more prevalent. [1,2] Breast cancer (BC) death and incidence rates adjusted for age are approximately 12.7 and 25.8 per 100,000 persons in India, respectively.[2] Right now, mortality rates are falling despite of rising incidence. Screening, early discovery, and better treatment may have impacted the decline.[3] The majority of female patients, in the imaging department, have a breast deformity that can be felt. The appropriate order and degree of imaging that are needed are still unclear.[4] Breast lumps have a relatively good predictive value for malignancy and are the most prevalent presenting symptom among women with breast cancer.[4] non-lump breast abnormalities such nipple retractions (7%) and breast discomfort (6%) as well as non-breast symptoms like back pain (1%) and weight loss (0.3%) are other less prevalent observations.[5]

Breast Symptomatology: Even with more aggressive treatment, the prognosis is not as excellent as in previous stages when over 50% of women with breast cancer are diagnosed in stages 3 and 4. Diseases may present later than expected for a variety of reasons, including ignorance, financial hardship, or lack of awareness. Early detection and diagnosis of BC are essential since they lower the province's death rate and raise the likelihood that patients will benefit from thorough medical care.[6] Beginning in the middle of the 1990s, developments in imaging technology fundamentally altered how women with detectable breast tumors were assessed. With the development of high-megahertz linear array transducers with improved near-field resolution, compound imaging, and harmonics, ultrasound technology applied to breast imaging significantly improved, resulting in improved characterization of the shape, margins, and internal echotexture of masses.[7] Mammography is necessary for women who have breast masses or lesions, but occasionally, especially in young women, heavy breast tissue limits the sensitivity of the scan. A suitable diagnostic method for identifying breast cancer under these circumstances is ultrasonic mammography. In addition to determining a breast's palpable mass, breast ultrasonography, also known as sonomammography, can remove cysts from solid masses and identify abnormalities in the peripheral view that mammography may miss.[8] The breast-imaging reporting and data system (BI-RADS) lexicon was created by the American College of Radiography as a common nomenclature to compile the results of several breast-imaging procedures, including MRI, USG, and MMG.[9] In our investigation, we also used the BI-RADS lexicon. In many instances, histopathological analysis is still the primary means of distinguishing benign from malignant lesions.[10]

Aims And Objectives

• To have a thorough understanding of the breast architecture, anatomical variations and pathologies to attain an optimal diagnostic approach.
• To have a clear understanding of the disease's specific location and scope, which is crucial for management decisions.
• To appropriately diagnose and stage any breast mass, including its site and any expansions that have migrated to neighboring structures.
• To correlate SMG diagnosis with histopathological findings.

This was a hospital based prospective study conducted among 100 female patients with symptoms affecting the breast who underwent sonomammographic imaging, at Shri B.M Patil Medical College, Hospital and Research Centre, over a period of 2 years from September 2022 to April 2024, after obtaining clearance from institutional ethics committee and written informed consent from the study participants.

Inclusion Criteria: The study included female patients above 15 years of age who presented with breast masses and those willing for follow-up.

Exclusion Criteria

Female patients with breast masses who have: -

• Not attained menarche
• Those with recurrent lesions.

Study procedure: We scanned the patients using GE VOLUSON S8 BT18 and GE VERSANA PREMIER machines.

The ipsilateral arm was abducted, the patient was positioned in a contralateral posterior oblique position, and the hand was placed beneath the head to flatten and thin the breast. The degree of posterior obliquity was varied to thin and flatten the portion of the breast undergoing sonographic evaluation. If a breast mass could only be felt when the patient is upright, then we occasionally performed US examination with the patient seated. A 9 MHz linear transducer was employed. We adjusted the depth of the initial US survey of the breast region of interest to allow visualization of the pectoralis muscle at the posterior edge of the field of view. We changed the initial gain settings to depict fat as a mid-level gray at all levels. During real-time scanning, time gain compensation was changed either manually or automatically based on convenience. We considered the background tissue surrounding the lesion to help with precise lesion correlation across several modalities. Similarly, while scanning a palpable abnormality, we paid special attention to the area of clinical concern to guarantee that we scanned the correct location. We touched the palpable anomaly with a finger, and the transducer was positioned immediately over the area. We changed the depth or field of view as necessary once we discovered a lesion or when looking we were looking for a subtle finding. When a mass was identified and the US settings are optimized, US "sweeps" were used to scan the lesion in numerous planes across its whole length. Pictures of the lesion were taken from both the radial and antiradial viewpoints, and they were labeled with the centimeters away from the nipple as well as the "right" or "left" clock face position. Both with and without calipers, photos were taken to enable margin assessment on still images. Three dimensions should be used to evaluate lesion size: the longest horizontal diameter should be reported first, then the anteroposterior diameter, and finally the orthogonal horizontal. Complementary Color and Power Doppler was performed to improve sensitivity in detecting malignant breast lesions. Sufficient care was to taken to eliminate artefacts. By comparing a lesion's strain to that of the surrounding normal tissue, strain ratios were calculated, and strain elastography was done. Elastography and B-mode US characteristics were carefully correlated. The social sciences statistical program (Version 25) was used to do statistical analysis after the obtained data was entered into an Excel sheet from Microsoft. Tables, and percentages were produced using the data distribution. Lastly, the relationship between the histological diagnosis and the SMG was examined using a Chi-square test. A cutoff point of p<0.05 was used for significance.

Statistical Methods

Data was entered in MS Excel and analyzed using SPSS software. Results were resented as tables.

SMG revealed a heterogenous breast composition with an oval-shaped, circumscribed, heterogenous lesion in parallel orientation, showing no significant posterior acoustic features in the 1 o’clock position of the right breast measuring about 1.4 x 1.6 x 0.8 cm. Adjacent duct ectasia was noted. The lesion showed no significant vascularity on Color Doppler Interrogation and was graded as soft on strain elastography. There was no evidence of calcifications, architectural distortion, skin changes or edema.

A diagnosis of an ACR BIRADS 2 lesion with features favoring a Fibroadenoma was made.

Histopathology returned a positive result for Fibroadenoma.

                                                           Image 2

SMG revealed a homogenous - fibroglandular breast composition with a large irregular-shaped, microlobulated, hypoechoic lesion in a not parallel orientation, showing posterior acoustic enhancement and architectural distortion measuring about 3.2 x 3 x 3.2 cm in the 8 to 10 o’clock position of the right breast. The lesion showed internal vascularity on Color Doppler Interrogation and were graded as intermediate on strain elastography. There was no evidence of skin changes, duct changes or edema.

A diagnosis of an ACR BIRADS 5 lesion with features favoring Breast Carcinoma was made.

Histopathology returned a positive result for Mucinous Breast Carcinoma Type B.

SMG also revealed a few enlarged lymph nodes with cortical thickening in the ipsilateral axillary region. The lesions showed no significant vascularity on Color Doppler Interrogation and were graded as hard on strain elastography. A diagnosis of Ipsilateral Nodal Metastasis was made. Histopathology returned a positive result for Malignant Nodal Deposits.

The ages of the patients ranged from 15 to 82 years. Most patients (n = 25) were within the age group of 31 - 40 years, followed by 24 patients between 21 - 29 years. Studies with a comparable age range (above 30 years) for the evaluation of sonomammography were reported by Devolli-Disha et al.[11]

It was also observed that patients between 20 and 50 years of age were more likely to present with multiple masses. 74.4% of the benign masses were found in patients younger than 40, whereas 91.7% of the malignant masses were found in patients aged more than 40. This suggests a positive relationship between the occurrence of malignancy and the increasing age of the patient.

A similar relationship was noted between the duration of symptoms and malignancy. 79 (66.9%) masses had a symptomatic history for less than a year, and 72 (91.1%) were benign. 29 (80.6%) of the malignant masses had a history of persisting for over a year.

Shape

31 (86.1%) of the 36 malignant masses displayed an irregular shape, while most benign lesions displayed either oval or round shapes. This data suggests a positive relationship between irregular shapes and malignancy and round or oval shapes with benignity.

Margin

69 (84.1%) of the benign masses had a circumscribed margin, which suggests a strong correlation between them. Masses with indistinct margins turned out to be benign in 12 cases. 83.3% of the malignant masses showed a lack of such a circumscribed margin and instead displayed indistinct margins in 6 masses, microlobulated margins in 7, angular margins in 8, and spiculated margins in 9.

Orientation

76 (92.7%) of all benign masses showed a parallel orientation. This starkly contrasts malignant masses, 27 (75%) of which showed a lack of parallel orientation.

Posterior Acoustic Features

Most of the masses evaluated did not feature any prominent posterior acoustic features. However, shadowing was observed to be observed 15 (41.7%) of the malignant masses. This is notable when compared to shadowing in only 3 (3.7%) of the 82 benign masses.

Calcifications

90 (76.3%) masses showed no evidence of calcific foci in the mass, duct or outside the mass. 70 (77.8%) of the masses were benign, and only 20 (22.2%) were malignant. Of the 25 (21.2%) masses that showed calcifications within, 14 (56%) turned out to be malignant, and 11 (44%) were benign. Both cases showing intraductal calcifications were malignant.

Vascularity

The majority of the masses observed did not display any significant internal vascularity (61.9%), and all but 2 of these masses turned out to be benign. In contrast, it was observed that a higher number of masses showing internal vascularity (38.1%) turned out to be malignant (75.5%). Further observation noted that 94.4% of all malignancies detected in the study showed internal vascularity. This data suggests a positive relationship between internal vascularity and malignancy.

McNicholas MM et al. demonstrated a significant overlap between benign and malignant lesions regarding presence and flow signal types on USG Doppler interrogation of breast masses. However, it was seen that malignant lesions were far more likely to show two or more discriminatory signal types.[12]

Elasticity

The masses that were found to be hard on strain elastography were found to be malignant in all but 2 of the cases. It was additionally found that 66.7% and 30.6% of the malignant masses were found to be hard and intermediate, respectively. This data suggests a positive relationship between the softness of a mass and benignity.

A study done by Kumar A et al showed that the sensitivity of elastography rose from 75.5% to 95.8% in the process of separating benign from malignant lesions.[13]

Lymph Node Involvement

Prominent lymph nodes were noted in 23 of the cases in the axillary region. 16 of the cases showed malignant deposits secondary to primary breast malignancy, while the other 7 were due to reactive lymphadenitis. The underlying etiology of enlargement of lymph nodes was accurately differentiated in all but one of the cases. The exception being a case of fat necrosis showing all the BIRADS characteristics suggestive of a tumor coupled with inappropriate and inadequate history due to the patient and patient attender’s recall bias misleading the clinical thought process.

In line with the findings published by Mendelson MB et al.[14] the current work used sonomammography to identify additional parameters such as lesion boundaries, echo patterns and other associated findings such as architectural distortion, duct changes, skin changes (thickening or retraction) and edema to distinguish between benign and malignant masses.

Each of the 118 masses were assigned a score and the findings correlated with histopathology. 53 (64.6%) of the masses were classified as BIRADS 2, and 10 (12.2%) came under BIRADS 3. These lesions were strongly suggested to be benign, and none of these masses were malignant on HPR correlation.

18 (15.3%) masses were scored as BIRADS 4a, indicating a low suspicion of malignancy. 16 (19.5%) of these turned out to be benign, whereas 2 (5.6%) were malignant. 7 (5.9%) BIRADS 4b class masses were found, out of which 5 were malignant. A notable case among 4b masses was a case of fat necrosis masquerading as a tumor. All 3 (2.5%) BIRADS 4c turned out to be malignant.

A total of 25 (21.2%) masses were given a BIRADS 5 score. 24 of these were malignant, with the exception of a case of granulomatous mastitis mimicking breast cancer. In addition, 2 (1.7%) biopsy-proven cases of breast cancer were also investigated, which fulfilled all the SMG lexicographic criteria for malignancy and were classified as BI-RADS.

The statistical analysis of BIRADS correlation with HPR shows a substantially high degree of concordance of BIRADS categories for distinguishing malignant masses from benign ones. Abdulla N et al. stated that subdivisions 4a, 4b, and 4c were poorly reproducible among radiologists, and there was a trend toward lower concordance for small masses and malignant lesions.[15] According to Heinig J et al, the assessment categories outlined in BIRADS for ultrasound[16] provide at least as good a means of distinguishing between malignant and benign solid masses as mammography does.

In this investigation, the sensitivity of sonomammography in identifying benign breast lesions was 97.56%, whereas the sensitivity for malignant lesions was 100%. The accuracy for various benign masses such as fibroadenomas (96.61%), fibrocystic disease and its variants (98.31%), galactocele (100%), lipoma (100%) and simple breast cysts (100%) was found to be relatively high, making SMG a reliable investigation in diagnosing benign masses.

Stavros et al[17] stated that some solid lesions can be properly classified as benign with sonography, enabling imaging follow-up rather than biopsy.

Similar high-accuracy statistics were noted for suspicious masses having a higher BIRADS score, such as breast abscesses (99.15%) and malignancies (98.31%).

Comparatively, sonomammography's sensitivity and specificity in this study were greater than Gonzaga’s study’s, which found that sonomammography's corresponding values were 57.1% and 62.8%, respectively.[18]

After doing a thorough analysis of the literature, Scheel et al.[19] discovered that adjunctive US screening for women with thick breasts improves cancer diagnosis when compared to mammography screening alone.

This observation was further consolidated in a study by Health Quality Ontario, which showed data demonstrating that screening with adjunct ultrasonography in addition to mammography detects more cases of disease with better sensitivity than mammography alone.[20] Thomassin-Naggara I, Tardivon A, Chopier J. (2014)[9] concluded that a good interpretation on imaging should respect the BI-RADS terminology's descriptive guidelines for accurate interpretation of images. High-resolution ultrasound is superior to other methods in several situations, according to Gupta K et al. These situations include the direct visualisation of intraductal masses with microcalcifications for guided biopsy, the distinction between solid and cystic lesions, the characterization of simple and complex cysts, the screening of mammographically inaccessible areas, and different lymph node stations.[21]

The overall accuracy of sonomammography in identifying benign and malignant masses is established in the current study by comparing the results of histology and sonomammography. Therefore, it can be applied as a screening study for breast masses.

However, adjunctive modalities like mammography, MR imaging and histopathological correlation are needed to characterize malignant masses

Most breast masses occur between 20 and 40 years of age. However, most malignant masses appear in patients older than 40. The lesions present as lumps in most cases with varying associated features. Most masses are unilateral, predominantly right-sided. The breast composition is divided such that heterogenous echotexture is seen predominantly in the younger age group, and the homogenous – fibroglandular variety is seen more commonly with increasing age. The most common location of the masses is the upper outer quadrant on either side, with the 3 o’clock position on the left side being the most common in this study. The incidence of malignancy increases with age and with delay in presentation following symptom onset. Most benign masses present with oval/round shape, circumscribed margin, parallel orientation, none or posterior acoustic enhancement and soft consistency on strain elastography. SMG shows some use in characterizing benign masses. Masses with BIRADS descriptors of irregular shape, angular/microlobulated/spiculated margins, not parallel orientation, shadowing, calcifications, internal vascularity and hard consistency on strain elastography are significantly more likely to be malignant. Additional features such as architectural distortion, skin changes (thickening and retraction), duct changes, and edema further help differentiate benign and malignant masses. Although SMG can reliably differentiate benign and malignant masses, complementary modalities such as MRI, mammography and histopathology are needed to characterize the malignant masses. Axillary lymph nodes are the first group to be involved in inflammatory and metastatic pathologies of the breast. Nodal metastasis can be reliably differentiated from reactive lymphadenitis using SMG combined with adequate clinical history. Good sensitivity and specificity are demonstrated by sonomammography in identifying all breast lesions. As such, it may be deemed a more appropriate method of inquiry than mammography. For individuals under 40 years of age, it can serve as the primary screening method for breast lumps. Breast lesions can be better understood and managed with the help of BI-RADS classification. The diagnostic accuracy of SMG can be further improved by combining it with complementary imaging modalities. Multimodality approach is more sensitive than any single modality alone. Unnecessary interventions can be avoided in unequivocally benign lesions on SMG.

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