The Impact of Mammographic, Radiologist, and Patient Factors on the Likelihood of Probably Benign (BI-RADS 3) Assessment at Diagnostic Mammography.

OBJECTIVE: To evaluate the association of mammographic, radiologist, and patient factors on BI-RADS 3 assessment at diagnostic mammography in patients recalled from screening mammography. METHODS: This Institutional Review Board-approved retrospective study of consecutive unique diagnostic mammography examinations in asymptomatic patients recalled from screening mammography March 5, 2014, to December 31, 2019, was conducted in a single large United States health care institution. Mammographic features (mass, calcification, distortion, asymmetry), breast density, prior examination, and BI-RADS assessment were extracted from reports by natural language processing. Patient age, race, and ethnicity were extracted from the electronic health record. Radiologist years in practice, recall rate, and number of interpreted diagnostic mammograms were calculated. A mixed effect logistic regression model evaluated factors associated with likelihood of BI-RADS 3 compared with other BI-RADS assessments. RESULTS: A total of 12 080 diagnostic mammography examinations were performed during the study period, yielding 2010 (16.6%) BI-RADS 3 and 10 070 (83.4%) other BI-RADS assessments. Asymmetry (odds ratio [OR] = 6.49, P <.001) and calcification (OR = 5.59, P <.001) were associated with increased likelihood of BI-RADS 3 assessment; distortion (OR = 0.20, P <.001), dense breast parenchyma (OR = 0.82, P <.001), prior examination (OR = 0.63, P = .01), and increasing patient age (OR = 0.99, P <.001) were associated with decreased likelihood. Mass, patient race or ethnicity, and radiologist factors were not significantly associated with BI-RADS 3 assessment. Malignancy rate for BI-RADS 3 lesions was 1.6%. CONCLUSION: Asymmetry and calcifications had an increased likelihood of BI-RADS 3 assessment at diagnostic evaluation with low likelihood of malignancy, while radiologist features had no association.

Diagnostic value of qualitative and quantitative enhancement parameters on contrast-enhanced mammography.

PURPOSE: To determine whether qualitative and quantitative enhancement parameters obtained from contrast-enhanced mammography (CEM) can be used in predicting malignancy. METHODS: After review board approval, consecutive 136 suspicious lesions with definite diagnosis were retrospectively analyzed on CEM. Acquisition was routinely started with craniocaudal view and ended with mediolateral oblique view of the affected breast. Lesion conspicuity (low, moderate, high), internal enhancement pattern (homogeneous, heterogeneous, rim), contrast-to-noise ratio (CNR), percentage of signal difference (PSD) and relative enhancement from early to late view were analyzed. PSD and relative enhancements were used to determine patterns of descending, steady or ascending enhancements. Receiver operating characteristic analysis, Cohen's kappa statistics and Spearman correlation tests were used. RESULTS: There were 29 benign and 107 malignant lesions. 64% of the malignant lesions exhibited high conspicuity compared to 14% of the benign lesions (P < 0.001). CNR values were higher in malignant lesions compared to benign ones (P ≤ 0.004). CNR from early view yielded 82% sensitivity, 72% specificity and PSD yielded 79% sensitivity, 65% specificity. Descending pattern and rim enhancement observed in 44% and 21% of breast cancers, respectively, and both provided 96% positive predictive value for malignancy. CONCLUSION: Diagnostic accuracy of quantitative parameters was higher than that of qualitative parameters. High CNR, rim enhancement, and descending pattern were features commonly seen in malignant lesions, while low CNR, homogeneous enhancement, and ascending pattern were commonly seen in benign lesions.

Classification of multi-feature fusion ultrasound images of breast tumor within category 4 using convolutional neural networks.

BACKGROUND: Breast tumor is a fatal threat to the health of women. Ultrasound (US) is a common and economical method for the diagnosis of breast cancer. Breast imaging reporting and data system (BI-RADS) category 4 has the highest false-positive value of about 30% among five categories. The classification task in BI-RADS category 4 is challenging and has not been fully studied. PURPOSE: This work aimed to use convolutional neural networks (CNNs) for breast tumor classification using B-mode images in category 4 to overcome the dependence on operator and artifacts. Additionally, this work intends to take full advantage of morphological and textural features in breast tumor US images to improve classification accuracy. METHODS: First, original US images coming directly from the hospital were cropped and resized. In 1385 B-mode US BI-RADS category 4 images, the biopsy eliminated 503 samples of benign tumor and left 882 of malignant. Then, K-means clustering algorithm and entropy of sliding windows of US images were conducted. Considering the diversity of different characteristic information of malignant and benign represented by original B-mode images, K-means clustering images and entropy images, they are fused in a three-channel form multi-feature fusion images dataset. The training, validation, and test sets are 969, 277, and 139. With transfer learning, 11 CNN models including DenseNet and ResNet were investigated. Finally, by comparing accuracy, precision, recall, F1-score, and area under curve (AUC) of the results, models which had better performance were selected. The normality of data was assessed by Shapiro-Wilk test. DeLong test and independent t-test were used to evaluate the significant difference of AUC and other values. False discovery rate was utilized to ultimately evaluate the advantages of CNN with highest evaluation metrics. In addition, the study of anti-log compression was conducted but no improvement has shown in CNNs classification results. RESULTS: With multi-feature fusion images, DenseNet121 has highest accuracy of 80.22 ± 1.45% compared to other CNNs, precision of 77.97 ± 2.89% and AUC of 0.82 ± 0.01. Multi-feature fusion improved accuracy of DenseNet121 by 1.87% from classification of original B-mode images (p < 0.05). CONCLUSION: The CNNs with multi-feature fusion show a good potential of reducing the false-positive rate within category 4. The work illustrated that CNNs and fusion images have the potential to reduce false-positive rate in breast tumor within US BI-RADS category 4, and make the diagnosis of category 4 breast tumors to be more accurate and precise.

Using Patient Navigation to Reduce Time to Diagnosis of Breast Cancer in Uganda.

PURPOSE: The Ugandan Ministry of Health adopted BI-RADS as standard of care in 2016. The authors performed a medical audit of breast ultrasound practices at four tertiary-level hospitals to assess interpretive performance. The authors also determined the effect of a low-cost navigation program linking breast imaging and pathology on the percentage of patients completing diagnostic care. METHODS: The authors retrieved 966 consecutive diagnostic breast ultrasound reports, with complete data, for studies performed on women aged >18 years presenting with symptoms of breast cancer between 2018 and 2020 from participating hospitals. Ultrasound results were linked to tumor registries and patient follow-up. A medical audit was performed according to the ACR's BI-RADS Atlas, fifth edition, and results were compared with those of a prior audit performed in 2013. At Mulago Hospital, an intervention was piloted on the basis of patient navigation, cost sharing, and same-day imaging, tissue sampling, and pathology. RESULTS: In total, 888 breast ultrasound examinations (91.9%) were eligible for inclusion. Compared with 2013, the postintervention cancer detection rate increased from 38 to 148.7 cancers per 1,000 examinations, positive predictive value 2 from 29.6% to 48.9%, and positive predictive value 3 from 62.7% to 79.9%. Specificity decreased from 90.5% to 87.7% and sensitivity from 92.3% to 81.1%. The mean time from tissue sampling to receipt of a diagnosis decreased from 60 to 7 days. The intervention increased the percentage of patients completing diagnostic care from 0% to 100%. CONCLUSIONS: Efforts to establish a culture of continuous quality improvement in breast ultrasound require robust data collection that links imaging results to pathology and patient follow-up. Interpretive performance met BI-RADS benchmarks for palpable masses, except sensitivity. This resource-appropriate strategy linking imaging, tissue sampling, and pathology interpretation decreased time to diagnosis and rates of loss to follow-up and improved the precision of the audit.

Characteristics of Suspicious Breast Lesions Visible Only on MR Imaging: Is It Possible to Classify into Immediate Biopsy and Careful Observation Groups?

PURPOSE: To investigate the characteristics of suspicious MRI-only visible lesions and to explore the validity of subcategorizing these lesions into the following two groups: lesions that would require immediate biopsy (4Bi) and lesions for which careful clinical follow-up could be recommended (4Fo). METHODS: A retrospective review of 108 MRI-only visible lesions in 106 patients who were diagnosed as Breast Imaging Reporting and Data System (BI-RADS) category 4 between June 2018 and June 2022 at our institution was performed by two radiologists. The breast MR images were evaluated according to BI-RADS and additional MRI descriptors (linear ductal, branching, and apparent diffusion coefficient values). The lesions were categorized by previously reported classification systems, and the positive predictive values (PPVs) for the different categories were determined and compared. Subsequently, a new classification system was developed in this study. RESULTS: The total malignancy rate was 31% (34/108). No significant differences between benign and malignant lesions were identified for focus and mass lesions. For non-mass lesions, linear ductal and heterogeneous internal enhancement suggested a benign lesion (P = 0.0013 and P = 0.023, respectively), and branching internal enhancement suggested malignancy (P = 0.0066). Segmental distribution suggested malignancy (P = 0.0097). However, the PPV of segmental distribution with heterogeneous enhancement was significantly lower than that of category 4 segmental lesions with other enhancement patterns (11% vs. 59%; P = 0.0198).As a new classification, the distribution of focal, linear, and segmental was given a score of 0, 1, or 2, and the internal enhancement of heterogeneous, linear-ductal, clumped, branching, and clustered-ring enhancement was given a score of 0, 1, 2, 3, and 4, respectively. When categorized using a scoring system, a statistically significant difference in PPV was observed between 4Fo (n = 27) and 4Bi (n = 33) (7% vs. 61%, P = 0.000029). CONCLUSION: The new classification system was found to be highly capable of subcategorizing BI-RADS category 4 MRI-only visible non-mass lesions into 4Fo and 4Bi.

Predictive value of contrast-enhanced ultrasonography and ultrasound elastography for management of BI-RADS category 4 nonpalpable breast masses.

PURPOSE: The objective of this study was to investigate the independent risk factors and associated predictive values of contrast-enhanced ultrasound (CEUS), shear wave elastography (SWE), and strain elastography (SE) for high-risk lesions (HRL) and malignant tumors (MT) among nonpalpable breast masses classified as BI-RADS category 4 on conventional ultrasound. METHODS: This prospective study involved consecutively admitted patients with breast tumors from January 2018, aiming to explore the management of BI-RADS category 4 breast tumors using CEUS and elastography. We conducted a retrospective review of patient data, focusing on those with a history of a nonpalpable mass as the primary complaint. Pathologic findings after surgical resection served as the gold standard. The CEUS arterial-phase indices were analyzed using contrast agent arrival-time parametric imaging processing mode, while quantitative and qualitative indices were examined on ES images. Independent risk factors were identified through binary logistic regression multifactorial analysis. The predictive efficacy of different modalities was compared using a receiver operating characteristics curve. Subsequently, a nomogram for predicting the risk of HRL/MT was established based on a multifactorial logistic regression model. RESULTS: A total of 146 breast masses from 146 patients were included, comprising 80 benign tumors, 12 HRLs, and 54 MTs based on the final pathology. There was no significant difference in pathologic size between the benign and HRL/MT groups [8.00(6.25,10.00) vs. 9.00(6.00,10.00), P = 0.506]. The diagnostic efficacy of US plus CEUS exceeded that of US plus SWE/SE for BI-RADS 4 nonpalpable masses, with an AUC of 0.954 compared to 0.798/0.741 (P ï¼œ 0.001). Further stratified analysis revealed a more pronounced improvement for reclassification of BI-RADS 4a masses (AUC: 0.943 vs. 0.762/0.675, P ï¼œ 0.001) than BI-RADS 4b (AUC:0.950 vs. 0.885/0.796, P＞0.05) with the assistance of CEUS than SWE/SE. Employing downgrade CEUS strategies resulted in negative predictive values ranging from 95.2 % to 100.0 % for BI-RADS 4a and 4b masses. Conversely, using upgrade nomogram strategies, which included the independent predictive risk factors of irregular enhanced shape, poor defined enhanced margin, earlier enhanced time, increased surrounding vessels, and presence of contrast agent retention, the diagnostic performance achieved an AUC of 0.947 with good calibration. CONCLUSION: After investigating the potential of CEUS and ES in improving risk assessment and diagnostic accuracy for nonpalpable BI-RADS category 4 breast masses, it is evident that CEUS has a more significant impact on enhancing classification compared to ES, particularly for BI-RADS 4a subgroup masses. This finding suggests that CEUS may offer greater benefits in improving risk assessment and diagnostic accuracy for this specific subgroup of breast masses.

Application of computer-aided diagnosis to predict malignancy in BI-RADS 3 breast lesions.

Purpose: To evaluate the ability of computer-aided diagnosis (CAD) system (S-Detect) to identify malignancy in ultrasound (US) -detected BI-RADS 3 breast lesions. Materials and methods: 148 patients with 148 breast lesions categorized as BI-RADS 3 were included in the study between January 2021 and September 2022. The malignancy rate, accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) were calculated. Results: In this study, 143 breast lesions were found to be benign, and 5 breast lesions were malignant (malignancy rate, 3.4 %, 95 % confidence interval (CI): 0.5-6.3). The malignancy rate rose significantly to 18.2 % (4/22, 95 % CI: 2.1-34.3) in the high-risk group with a "possibly malignant" CAD result (p = 0.017). With a "possibly benign" CAD result, the malignancy rate decreased to 0.8 % (1/126, 95 % CI: 0-2.2) in the low-risk group (p = 0.297). The AUC, sensitivity, specificity, accuracy, PPV, and NPV of the CAD system in BI-RADS 3 breast lesions were 0.837 (95 % CI: 77.7-89.6), 80.0 % (95 % CI: 73.6-86.4), 87.4 % (95 % CI: 82.0-92.7), 87.2 % (95 % CI: 81.8-92.6), 18.2 % (95 % CI: 2.1-34.3) and 99.2 % (95 % CI: 97.8-100.0), respectively. Conclusions: CAD system (S-Detect) enables radiologists to distinguish a high-risk group and a low-risk group among US-detected BI-RADS 3 breast lesions, so that patients in the low-risk group can receive follow-up without anxiety, while those in the high-risk group with a significantly increased malignancy rate should actively receive biopsy to avoid delayed diagnosis of breast cancer.

MRI Insights in Breast Imaging.

In the world, breast cancer is the most commonly diagnosed cancer among women. Currently, MRI is the most sensitive breast imaging method for detecting breast cancer, although false positive rates are still an issue. To date, the accuracy of breast MRI is widely recognized across various clinical scenarios, in particular, staging of known cancer, screening for breast cancer in high-risk women, and evaluation of response to neoadjuvant chemotherapy. Since technical development and further clinical indications have expanded over recent years, dedicated breast radiologists need to constantly update their knowledge and expertise to remain confident and maintain high levels of diagnostic performance in breast MRI. This review aims to detail current and future applications of breast MRI, from technological requirements and advances to new multiparametric and abbreviated protocols, and ultrafast imaging, as well as current and future indications.

The utility of quantifying the orientation of breast masses in ultrasound imaging.

The aim of this study was to quantify the orientation of breast masses and determine whether it can enhance the utility of a not parallel orientation in predicting breast mass malignancy. A total of 15,746 subjects who underwent breast ultrasound examinations were initially enrolled in the study. Further evaluation was performed on subjects with solid breast masses (≤ 5 cm) intended for surgical resection and/or biopsy. The orientation angle, defined as the acute angle between the align of the maximal longitudinal diameter of the breast mass and the surface of the breast skin, was measured. Receiver operating characteristic (ROC) curve analysis was conducted, and various performance measures including sensitivity, specificity, positive and negative predictive values, accuracy, odds ratio, and the area under the ROC curve (AUC) were calculated. Multivariate analysis was performed to determine if the orientation angle was an independent predictor of breast malignancy. Decision curve analysis (DCA) was also conducted to assess the net benefit of adopting the orientation angle for predicting breast mass malignancy. The final analysis included 83 subjects with breast cancer and 135 subjects with benign masses. The intra-group correlation coefficient for the measurement of the orientation angle of breast masses was 0.986 (P = 0.001), indicating high reproducibility. The orientation angles of malignant and benign breast masses were 36.51 ± 14.90 (range: 10.7-88.6) degrees and 15.28 ± 8.40 (range: 0.0-58.7) degrees, respectively, and there was a significant difference between them (P < 0.001). The cutoff value for the orientation angle was determined to be 22.9°. The sensitivity, specificity, positive and negative predictive values, accuracy, odds ratio, and AUC for the prediction of breast malignancy using the orientation angle were 88.0%, 87.4%, 81.1%, 92.2%, 87.6%, 50.67%, and 0.925%, respectively. Multivariate analysis revealed that the orientation angle (> 22.9°), not circumscribed margin, and calcifications of the breast mass were independent factors predicting breast malignancy. The net benefit of adopting the orientation angle for predicting breast malignancy was 0.303. Based on these findings, it can be concluded that quantifying the orientation angle of breast masses is useful in predicting breast malignancy, as it demonstrates high sensitivity, specificity, AUC, and standardized net benefit. It optimizes the utility of the not parallel orientation in assessing breast mass malignancy.

Combining Potential Strain Elastography and Radiomics for Diagnosing Breast Lesions in BI-RADS 4: Construction and Validation a Predictive Nomogram.

RATIONALE AND OBJECTIVES: To develop a nomogram by integrating B-mode ultrasound (US), strain ratio (SR), and radiomics signature (RS) effectively differentiating between benign and malignant lesions in the Breast Imaging Reporting and Data System (BI-RADS) 4. MATERIALS AND METHODS: We retrospectively recruited 709 consecutive patients who were assigned a BI-RADS 4 and underwent curative resection or biopsy between 2017 and 2022. US images were collected before surgery. A RS was developed through a multistep feature selection and construction process. Histology findings served as the gold standard. Univariate and multivariate regression analysis were employed to analyze the clinical and US characteristics and identify variables for developing a nomogram. The calibration and discrimination of the nomogram were conducted to evaluate its performance. RESULTS: The study included a total of 709 patients, with 497 in the training set and 212 in the validation set. In the training set, the B-mode US had an AUC of 0.84 (95% confidence interval [CI], 0.80, 0.87). The SR demonstrated an AUC of 0.78 (95% CI, 0.74, 0.82), while the RS showed an AUC of 0.85 (95% CI, 0.81, 0.88). Notably, the nomogram exhibited superior performance compared to the conventional US, SR, and RS (AUC=0.93, both p < 0.05, as per the Delong test). The clinical usefulness of the nomogram was favorable. CONCLUSION: The calibrated nomogram can be specifically designed to predict the malignancy of breast lesions in the BI-RADS 4 category.

Breast Cancer Screening and BI-RADS Scoring Trends Before and During the COVID-19 Pandemic in an Academic Safety-Net Hospital.

BACKGROUND: Little is known about how the COVID-19 pandemic affected screening mammography rates and Breast Imaging Reporting and Data Systems (BI-RADS) categorizations within populations facing social and economic inequities. Our study seeks to compare trends in breast cancer screening and BI-RADS assessments in an academic safety-net patient population before and during the COVID-19 pandemic. PATIENTS AND METHODS: Our single-center retrospective study evaluated women ≥ 18 years old with no known breast cancer diagnosis who received breast cancer screening from March 2019-September 2020. The screening BI-RADS score, completion of recommended diagnostic imaging, and diagnostic BI-RADS scores were compared between the pre-COVID-19 era (from 1 March 2019 to 19 March 2020) and COVID-19 era (from 20 March 2020 to 30 September 2020). RESULTS: Among the 11,798 patients identified, screened patients were younger (median age 57 versus 59 years, p < 0.001) and more likely covered by private insurance (35.9% versus 32.3%, p < 0.001) during the COVID-19 era compared with the pre-COVID-19 era. During the pandemic, there was an increase in screening mammograms categorized as BI-RADS 0 compared with the pre-COVID-19 era (20% versus 14.5%, p < 0.0001). There was no statistically significant difference in rates of completion of diagnostic imaging (81.6% versus 85.4%, p = 0.764) or assignment of suspicious BI-RADS scores (BI-RADS 4-5; 79.9% versus 80.8%, p = 0.762) between the two eras. CONCLUSIONS: Although more patients were recommended to undergo diagnostic imaging during the pandemic, there were no significant differences in race, completion of diagnostic imaging, or proportions of mammograms categorized as suspicious between the two time periods. These findings likely reflect efforts to maintain equitable care among diverse racial groups served by our safety-net hospital.

Beyond BI-RADS: Nonmass Abnormalities on Breast Ultrasound.

Abnormalities on breast ultrasound (US) images which do not meet the criteria for masses are referred to as nonmass lesions. These features and outcomes have been investigated in several studies conducted by Asian researchers. However, the term "nonmass" is not included in the American College of Radiology (ACR) Breast Imaging Reporting and Data System (BI-RADS) 5th edition for US. According to the Japan Association of Breast and Thyroid Sonology guidelines, breast lesions are divided into mass and nonmass. US findings of nonmass abnormalities are classified into five subtypes: abnormalities of the ducts, hypoechoic areas in the mammary glands, architectural distortion, multiple small cysts, and echogenic foci without a hypoechoic area. These findings can be benign or malignant; however, focal or segmental distributions and presence of calcifications suggest malignancy. Intraductal, invasive ductal, and lobular carcinomas can present as nonmass abnormalities. For the nonmass concept to be included in the next BI-RADS and be widely accepted in clinical practice, standardized terminologies, an interpretation algorithm, and outcome-based evidence are required for both screening and diagnostic US.

Development and Validation of a Nomogram for Predicting Breast Malignancy in Male Patients Based on Clinical and Ultrasound Features.

OBJECTIVE: This study aimed to construct a nomogram based on clinical and ultrasound (US) features to predict breast malignancy in males. METHODS: The medical records between August, 2021 and February, 2023 were retrospectively collected from the database. Patients included in this study were randomly divided into training and validation sets in a 7:3 ratio. The models for predicting the risk of malignancy in male patients with breast lesions were virtualized by the nomograms. RESULTS: Among the 71 enrolled patients, 50 were grouped into the training set, while 21 were grouped into the validation set. After the multivariate analysis was done, pain, BI-RADS category, and elastography score were identified as the predictors for malignancy risk and were selected to generate the nomogram. The C-index was 0.931 for the model. Concordance between predictions and observations was detected by calibration curves and was found to be good in this study. The model achieved a net benefit across all threshold probabilities, which was shown by the decision curve analysis (DCA) curve. CONCLUSION: We successfully constructed a nomogram to evaluate the risk of breast malignancy in males using clinical and US features, including pain, BI-RADS category, and elastography score, which yielded good predictive performance.

Follow-up results of BI-RADS 3 lesions on magnetic resonance imaging: a retrospective study.

PURPOSE: The categorization of Breast Imaging Reporting and Data System (BI-RADS) 3 lesions is not as clear in magnetic resonance imaging (MRI) as it is in mammography (MG). With the increasing number of MRI scans currently being conducted globally, incidentally detected lesions falling into the probably benign category are frequently being observed. In this study, our aim was to investigate the imaging characteristics and follow-up results of BI-RADS 3 lesions detected by MRI and to determine their malignancy rates. METHODS: Breast MRI scans performed between January 2010 and January 2020 and classified as BI-RADS 3 lesions were retrospectively analyzed. The study included 216 lesions with known biopsy or surgical excision results or with at least one year of radiological follow-up. We assessed the patients' age, the presence of breast cancer, the follow-up interval, and the imaging findings at the beginning and during the follow-up. Lesions that remained stable, disappeared, or decreased in size and had a benign histopathological diagnosis were classified as benign. Lesions with the histopathological diagnosis of malignancy, identified by either biopsy or surgical excision, were classified as malignant. We determined the malignancy rate based on the histopathology and follow-up results. RESULTS: Considering the follow-up results of all cases, 8% of lesions were excised, 0.5% decreased in size, 1.4% became enlarged, 17.1% disappeared, and 73% remained stable. The malignancy rate was 2.8%. A significant relationship was found between lesion shape and malignancy, as progression to malignancy was more likely in round lesions than in other types. An irregular margin, heterogeneous enhancement, and kinetic curve (type 2) features were significant for lesion upgrade to malignancy. CONCLUSION: The malignancy rate in BI-RADS 3 lesions detected by MRI is low and falls within the accepted cancer rate for MG and sonography. Changes in size, morphology, and enhancement pattern should be considered in terms of malignancy development during follow-up. The follow-up intervals should be determined on a case-by-case basis.

Nonmass Lesions on Breast US: An International Perspective on Clinical Use and Outcomes.

Nonmass lesions (NMLs) on breast US are defined as discrete areas of altered echotexture compared to surrounding breast tissue and lack the 3-dimensionality of a mass. They are not a component of American College of Radiology BI-RADS, but they are a finding type included in the Japan Association of Breast and Thyroid Sonology lexicon. Use of the NML finding is routine in many Asian practices, including the Samsung Medical Center and Seoul National University Hospital, and their features and outcomes have been investigated in multiple studies. Nonmass lesions are most often observed when US is used to evaluate mammographic asymmetries, suspicious calcifications, and nonmass enhancement on MRI and contrast-enhanced mammography. Nonmass lesions can be described by their echogenicity, distribution, presence or absence of associated calcifications, abnormal duct changes, architectural distortion, posterior shadowing, small cysts, and hypervascularity. Malignant lesions, especially ductal carcinoma in situ, can manifest as NMLs on US. There is considerable overlap between the US features of benign and malignant NMLs, and they also must be distinguished from normal variants. The literature indicates that NMLs with linear or segmental distribution, associated calcifications, abnormal duct changes, posterior shadowing, and hypervascularity are suggestive of malignancy, whereas NMLs with only interspersed small cysts are usually benign fibrocystic changes. In this article, we introduce the concepts of NMLs, illustrate US features suggestive of benign and malignant etiologies, and discuss our institutional approach for evaluating NMLs and an algorithm that we use to guide interpretation in clinical practice.

Rate and Timeliness of Diagnostic Evaluation and Biopsy After Recall From Screening Mammography in the National Mammography Database.

OBJECTIVE: To describe the rate and timeliness of diagnostic resolution after an abnormal screening mammogram in the ACR's National Mammography Database. METHODS: Abnormal screening mammograms (BI-RADS 0 assessment) in the National Mammography Database from January 1, 2008, to December 31, 2021, were retrospectively identified. The rates and timeliness of follow-up with diagnostic evaluation and biopsy were assessed and compared across patient and facility demographics. RESULTS: Among the 2,874,310 screening mammograms reported as abnormal, follow-up was documented in 66.4% (n = 1,909,326). Lower follow-up rates were observed in younger women (59.4% in women < 30 years, 63.2% in women 30-39 years), Black (57.4%) and American Indian (59.5%) women, and women with no breast cancer family history (63.0%). The overall median time to diagnostic evaluation was 9 days. Longer median diagnostic evaluation time was noted in Black (14 days), other or mixed race (14 days), and Hispanic women (13 days). Of the 318,977 recalled screening mammograms recommended for biopsy, 238,556 (74.8%) biopsies were documented. Lower biopsy rates were noted in older women (71.5% in women aged ≥80) and Black (71.5%) and American Indian (52.2%) women. The overall median time from diagnostic evaluation to biopsy was 21 days. Longer median biopsy time was noted in older (23 days aged ≥80), Black (25 days), mixed or other race (26 days), and Hispanic women (23 days), and rural (24 days) or community hospital affiliated facilities (22 days). DISCUSSION: There is variability in the rates and timeliness of diagnostic evaluation and biopsy in women with abnormal screening mammogram. Subsets of women and facilities could benefit from targeted interventions to promote timely diagnostic resolution and biopsy after an abnormal screening mammogram.

Exploring the Relationship Between CD 166 Expression and Breast Imaging Reporting and Data System (BI-RADS) Scores in Breast Cancer Patients and Healthy Volunteers.

BACKGROUND: This research embarked on a crucial endeavor to clarify the connection between levels of CD166 expression and the established Breast Imaging Reporting and Data System (BI-RADS) grading system. Through a comprehensive exploration of this correlation, the objective was to ascertain if CD166 could function as an additional biomarker, enhancing the predictive effectiveness of the BI-RADS classification. METHOD: This prospective observational study involved 81 women with histopathologically confirmed early breast tumors and 81 radiologically confirmed healthy breast volunteers. The BI-RADS scores of all the participants included in the study were recorded. Before starting treatment, serum, saliva, and urine samples were collected. The CD166 levels were quantified using an enzyme-linked immunosorbent assay. RESULTS: The study involved the analysis and comparison of the mean and standard deviations of CD166 expression in serum, saliva, and urine across various BI-RADS categories. Notably, statistically significant differentiation was found (p=0.00) across all samples spanning the spectrum of BI-RADS categories. CONCLUSION: A progressive rise in CD166 concentration coincides with the increasing gradient of the BI-RADS category, implying a possible link between CD166 and breast cancer progression and severity.

A Deep Learning Decision Support Tool to Improve Risk Stratification and Reduce Unnecessary Biopsies in BI-RADS 4 Mammograms.

Purpose: To evaluate the performance of a biopsy decision support algorithmic model, the intelligent-augmented breast cancer risk calculator (iBRISK), on a multicenter patient dataset. Materials and Methods: iBRISK was previously developed by applying deep learning to clinical risk factors and mammographic descriptors from 9700 patient records at the primary institution and validated using another 1078 patients. All patients were seen from March 2006 to December 2016. In this multicenter study, iBRISK was further assessed on an independent, retrospective dataset (January 2015-June 2019) from three major health care institutions in Texas, with Breast Imaging Reporting and Data System (BI-RADS) category 4 lesions. Data were dichotomized and trichotomized to measure precision in risk stratification and probability of malignancy (POM) estimation. iBRISK score was also evaluated as a continuous predictor of malignancy, and cost savings analysis was performed. Results: The iBRISK model's accuracy was 89.5%, area under the receiver operating characteristic curve (AUC) was 0.93 (95% CI: 0.92, 0.95), sensitivity was 100%, and specificity was 81%. A total of 4209 women (median age, 56 years [IQR, 45-65 years]) were included in the multicenter dataset. Only two of 1228 patients (0.16%) in the "low" POM group had malignant lesions, while in the "high" POM group, the malignancy rate was 85.9%. iBRISK score as a continuous predictor of malignancy yielded an AUC of 0.97 (95% CI: 0.97, 0.98). Estimated potential cost savings were more than $420 million. Conclusion: iBRISK demonstrated high sensitivity in the malignancy prediction of BI-RADS 4 lesions. iBRISK may safely obviate biopsies in up to 50% of patients in low or moderate POM groups and reduce biopsy-associated costs.Keywords: Mammography, Breast, Oncology, Biopsy/Needle Aspiration, Radiomics, Precision Mammography, AI-augmented Biopsy Decision Support Tool, Breast Cancer Risk Calculator, BI-RADS 4 Mammography Risk Stratification, Overbiopsy Reduction, Probability of Malignancy (POM) Assessment, Biopsy-based Positive Predictive Value (PPV3) Supplemental material is available for this article. Published under a CC BY 4.0 license.See also the commentary by McDonald and Conant in this issue.

Artificial Intelligence in BI-RADS Categorization of Breast Lesions on Ultrasound: Can We Omit Excessive Follow-ups and Biopsies?

RATIONALE AND OBJECTIVES: Artificial intelligence (AI) systems have been increasingly applied to breast ultrasonography. They are expected to decrease the workload of radiologists and to improve diagnostic accuracy. The aim of this study is to evaluate the performance of an AI system for the BI-RADS category assessment in breast masses detected on breast ultrasound. MATERIALS AND METHODS: A total of 715 masses detected in 530 patients were analyzed. Three breast imaging centers of the same institution and nine breast radiologists participated in this study. Ultrasound was performed by one radiologist who obtained two orthogonal views of each detected lesion. These images were retrospectively reviewed by a second radiologist blinded to the patient's clinical data. A commercial AI system evaluated images. The level of agreement between the AI system and the two radiologists and their diagnostic performance were calculated according to dichotomic BI-RADS category assessment. RESULTS: This study included 715 breast masses. Of these, 134 (18.75%) were malignant, and 581 (81.25%) were benign. In discriminating benign and probably benign from suspicious lesions, the agreement between AI and the first and second radiologists was moderate statistically. The sensitivity and specificity of radiologist 1, radiologist 2, and AI were calculated as 98.51% and 80.72%, 97.76% and 75.56%, and 98.51% and 65.40%, respectively. For radiologist 1, the positive predictive value (PPV) was 54.10%, the negative predictive value (NPV) was 99.58%, and the accuracy was 84.06%. Radiologist 2 achieved a PPV of 47.99%, NPV of 99.32%, and accuracy of 79.72%. The AI system exhibited a PPV of 39.64%, NPV of 99.48%, and accuracy of 71.61%. Notably, none of the lesions categorized as BI-RADS 2 by AI were malignant, while 2 of the lesions classified as BI-RADS 3 by AI were subsequently confirmed as malignant. By considering AI-assigned BI-RADS 2 as safe, we could potentially avoid 11% (18 out of 163) of benign lesion biopsies and 46.2% (110 out of 238) of follow-ups. CONCLUSION: AI proves effective in predicting malignancy. Integrating it into the clinical workflow has the potential to reduce unnecessary biopsies and short-term follow-ups, which, in turn, can contribute to sustainability in healthcare practices.

A comparative study on the features of breast sclerosing adenosis and invasive ductal carcinoma via ultrasound and establishment of a predictive nomogram.

Objective: To analyze the clinical and ultrasonic characteristics of breast sclerosing adenosis (SA) and invasive ductal carcinoma (IDC), and construct a predictive nomogram for SA. Materials and methods: A total of 865 patients were recruited at the Second Hospital of Shandong University from January 2016 to November 2022. All patients underwent routine breast ultrasound examinations before surgery, and the diagnosis was confirmed by histopathological examination following the operation. Ultrasonic features were recorded using the Breast Imaging Data and Reporting System (BI-RADS). Of the 865 patients, 203 (252 nodules) were diagnosed as SA and 662 (731 nodules) as IDC. They were randomly divided into a training set and a validation set at a ratio of 6:4. Lastly, the difference in clinical characteristics and ultrasonic features were comparatively analyzed. Result: There was a statistically significant difference in multiple clinical and ultrasonic features between SA and IDC (P<0.05). As age and lesion size increased, the probability of SA significantly decreased, with a cut-off value of 36 years old and 10 mm, respectively. In the logistic regression analysis of the training set, age, nodule size, menopausal status, clinical symptoms, palpability of lesions, margins, internal echo, color Doppler flow imaging (CDFI) grading, and resistance index (RI) were statistically significant (P<0.05). These indicators were included in the static and dynamic nomogram model, which showed high predictive performance, calibration and clinical value in both the training and validation sets. Conclusion: SA should be suspected in asymptomatic young women, especially those younger than 36 years of age, who present with small-size lesions (especially less than 10 mm) with distinct margins, homogeneous internal echo, and lack of blood supply. The nomogram model can provide a more convenient tool for clinicians.