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Objectives: We evaluated whether lesion-to-fat ratio measured by shear wave elastography in patients with Breast Imaging Reporting and Data System (BI-RADS) 3 or 4 lesions has the potential to further refine the assessment of B-mode ultrasound alone in breast cancer diagnostics., Methods: This was a secondary analysis of an international diagnostic multicenter trial (NCT02638935). Data from 1288 women with breast lesions categorized as BI-RADS 3 and 4a-c by conventional B-mode ultrasound were analyzed, whereby the focus was placed on differentiating lesions categorized as BI-RADS 3 and BI-RADS 4a. All women underwent shear wave elastography and histopathologic evaluation functioning as reference standard. Reduction of benign biopsies as well as the number of missed malignancies after reclassification using lesion-to-fat ratio measured by shear wave elastography were evaluated., Results: Breast cancer was diagnosed in 368 (28.6%) of 1288 lesions. The assessment with conventional B-mode ultrasound resulted in 53.8% (495 of 1288) pathologically benign lesions categorized as BI-RADS 4 and therefore false positives as well as in 1.39% (6 of 431) undetected malignancies categorized as BI-RADS 3. Additional lesion-to-fat ratio in BI-RADS 4a lesions with a cutoff value of 1.85 resulted in 30.11% biopsies of benign lesions which correspond to a reduction of 44.04% of false positives., Conclusions: Adding lesion-to-fat ratio measured by shear wave elastography to conventional B-mode ultrasound in BI-RADS 4a breast lesions could help reduce the number of benign biopsies by 44.04%. At the same time, however, 1.98% of malignancies were missed, which would still be in line with American College of Radiology BI-RADS 3 definition of <2% of undetected malignancies., (© 2023 The Authors. Journal of Ultrasound in Medicine published by Wiley Periodicals LLC on behalf of American Institute of Ultrasound in Medicine.)

Purpose:  In this prospective, multicenter trial we evaluated whether additional shear wave elastography (SWE) for patients with BI-RADS 3 or 4 lesions on breast ultrasound could further refine the assessment with B-mode breast ultrasound for breast cancer diagnosis., Materials and Methods:  We analyzed prospective, multicenter, international data from 1288 women with breast lesions rated by conventional 2 D B-mode ultrasound as BI-RADS 3 to 4c and undergoing 2D-SWE. After reclassification with SWE the proportion of undetected malignancies should be < 2 %. All patients underwent histopathologic evaluation (reference standard)., Results:  Histopathologic evaluation showed malignancy in 368 of 1288 lesions (28.6 %). The assessment with B-mode breast ultrasound resulted in 1.39 % (6 of 431) undetected malignancies (malignant lesions in BI-RADS 3) and 53.80 % (495 of 920) unnecessary biopsies (biopsies in benign lesions). Re-classifying BI-RADS 4a patients with a SWE cutoff of 2.55 m/s resulted in 1.98 % (11 of 556) undetected malignancies and a reduction of 24.24 % (375 vs. 495) of unnecessary biopsies., Conclusion:  A SWE value below 2.55 m/s for BI-RADS 4a lesions could be used to downstage these lesions to follow-up, and therefore reduce the number of unnecessary biopsies by 24.24 %. However, this would come at the expense of some additionally missed cancers compared to B-mode breast ultrasound (rate of undetected malignancies 1.98 %, 11 of 556, versus 1.39 %, 6 of 431) which would, however, still be in line with the ACR BI-RADS 3 definition (< 2 % of undetected malignancies)., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Background: Breast ultrasound identifies additional carcinomas not detected in mammography but has a higher rate of false-positive findings. We evaluated whether use of intelligent multi-modal shear wave elastography (SWE) can reduce the number of unnecessary biopsies without impairing the breast cancer detection rate., Methods: We trained, tested, and validated machine learning algorithms using SWE, clinical, and patient information to classify breast masses. We used data from 857 women who underwent B-mode breast ultrasound, SWE, and subsequent histopathologic evaluation at 12 study sites in seven countries from 2016 to 2019. Algorithms were trained and tested on data from 11 of the 12 sites and externally validated using the additional site's data. We compared findings to the histopathologic evaluation and compared the diagnostic performance between B-mode breast ultrasound, traditional SWE, and intelligent multi-modal SWE., Results: In the external validation set (n = 285), intelligent multi-modal SWE showed a sensitivity of 100% (95% CI, 97.1-100%, 126 of 126), a specificity of 50.3% (95% CI, 42.3-58.3%, 80 of 159), and an area under the curve of 0.93 (95% CI, 0.90-0.96). Diagnostic performance was significantly higher compared to traditional SWE and B-mode breast ultrasound (P < 0.001). Unlike traditional SWE, positive-predictive values of intelligent multi-modal SWE were significantly higher compared to B-mode breast ultrasound. Unnecessary biopsies were reduced by 50.3% (79 versus 159, P < 0.001) without missing cancer compared to B-mode ultrasound., Conclusion: The majority of unnecessary breast biopsies might be safely avoided by using intelligent multi-modal SWE. These results may be helpful to reduce diagnostic burden for patients, providers, and healthcare systems., Competing Interests: Conflict of interest statement The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Shear wave elastography (SWE) and strain elastography (SE) have shown promising potential in breast cancer diagnostics by evaluating the stiffness of a lesion. Combining these two techniques could further improve the diagnostic performance. We aimed to exploratorily define the cut-offs at which adding combined SWE and SE to B-mode breast ultrasound could help reclassify Breast Imaging Reporting and Data System (BI-RADS) 3-4 lesions to reduce the number of unnecessary breast biopsies., Methods: We report the secondary results of a prospective, multicentre, international trial (NCT02638935). The trial enrolled 1288 women with BI-RADS 3 to 4c breast masses on conventional B-mode breast ultrasound. All patients underwent SWE and SE (index test) and histopathologic evaluation (reference standard). Reduction of unnecessary biopsies (biopsies in benign lesions) and missed malignancies after recategorising with SWE and SE were the outcome measures., Results: On performing histopathologic evaluation, 368 of 1288 breast masses were malignant. Following the routine B-mode breast ultrasound assessment, 53.80% (495 of 920 patients) underwent an unnecessary biopsy. After recategorising BI-RADS 4a lesions (SWE cut-off ≥3.70 m/s, SE cut-off ≥1.0), 34.78% (320 of 920 patients) underwent an unnecessary biopsy corresponding to a 35.35% (320 versus 495) reduction of unnecessary biopsies. Malignancies in the new BI-RADS 3 cohort were missed in 1.96% (12 of 612 patients)., Conclusion: Adding combined SWE and SE to routine B-mode breast ultrasound to recategorise BI-RADS 4a patients could help reduce the number of unnecessary biopsies in breast diagnostics by about 35% while keeping the rate of undetected malignancies below the 2% ACR BI-RADS 3 definition., Competing Interests: Conflict of interest statement The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Purpose:  The aim of the present study was to determine the accuracy of breast cancer measurement with 2 D shear wave elastography (2 D SWE), B-mode ultrasound, and mammography by comparing these methods with the actual histopathological tumor size., Materials and Methods:  135 patients with proven malignant breast lesions at two centers were included in a prospective study. The maximum lesion diameter was measured by 2 D SWE, B-mode ultrasound, and mammography. After surgery, the histopathological tumor size was measured by a pathologist., Results:  The mean difference in tumor size on 2 D SWE, B-mode ultrasound, and mammography on the one hand, and the actual tumor size on the other, was -0.03 cm, 0.16 cm and 0.10 cm, respectively. Lesion size on histopathological investigation was overestimated by 2 D SWE (p = 0.004) and underestimated by B-mode imaging (p < 0.001). All three imaging methods underestimated the size of invasive lobular cancers and lesions > 15 mm; 2 D SWE was most accurate in this regard., Conclusion:  2 D SWE predicted lesion size more precisely than B-mode ultrasound or mammography. In cases of invasive lobular carcinoma, all three imaging methods underestimated lesion size, with 2 D SWE coming closest to the actual tumor size., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: To determine the benefit of ShearWave™ Elastography (SWE™) in the ultrasound characterization of BI-RADS® 3 breast lesions in a diagnostic population., Materials and Methods: 303 BI-RADS® 3 lesions (mean size: 13.2 mm, SD: 7.5 mm) from the multicenter BE1 prospective study population were analyzed: 201 (66%) had cytology or core biopsy, and the remaining 102 had a minimum follow-up of one year; 8 (2.6%) were malignant. 7 SWE features were evaluated with regard to their ability to downgrade benign BI-RADS® 3 masses. The performance of each SWE feature was assessed by evaluating the number of lesions correctly reclassified and the impact on cancer rates within the new BI-RADS® 3' lesion group., Results: No malignancies were found with an E-color "black to dark blue", which allowed the downgrading of 110/303 benign masses (p < 0.0001), with a non-significant increase in BI-RADS® 3' malignancy rate from 2.6% to 4.1%. E-max ≤ 20 kPa (2.6 m/s) was able to downgrade 48/303 (p < 0.0001) lesions with a lower increase in BI-RADS® 3' malignancy rate (3.1%). No other SWE features were useful for reclassifying benign BI-RADS® 3 lesions., Conclusion: Applying simple reclassification rules, SWE assessment of the maximum stiffness of lesions allowed the downgrading of a sub-group of benign BI-RADS® 3 lesions. This was accompanied by a non-significant increase in the malignancy rate in the new BI-RADS® 3 class., (© Georg Thieme Verlag KG Stuttgart · New York.)

The clinical part of these Guidelines and Recommendations produced under the auspices of the European Federation of Societies for Ultrasound in Medicine and Biology EFSUMB assesses the clinically used applications of all forms of elastography, stressing the evidence from meta-analyses and giving practical advice for their uses and interpretation. Diffuse liver disease forms the largest section, reflecting the wide experience with transient and shear wave elastography . Then follow the breast, thyroid, gastro-intestinal tract, endoscopic elastography, the prostate and the musculo-skeletal system using strain and shear wave elastography as appropriate. The document is intended to form a reference and to guide clinical users in a practical way., (© Georg Thieme Verlag KG Stuttgart · New York.)

The technical part of these Guidelines and Recommendations, produced under the auspices of EFSUMB, provides an introduction to the physical principles and technology on which all forms of current commercially available ultrasound elastography are based. A difference in shear modulus is the common underlying physical mechanism that provides tissue contrast in all elastograms. The relationship between the alternative technologies is considered in terms of the method used to take advantage of this. The practical advantages and disadvantages associated with each of the techniques are described, and guidance is provided on optimisation of scanning technique, image display, image interpretation and some of the known image artefacts., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: To determine whether adding shear-wave (SW) elastographic features could improve accuracy of ultrasonographic (US) assessment of breast masses., Materials and Methods: From September 2008 to September 2010, 958 women consented to repeat standard breast US supplemented by quantitative SW elastographic examination in this prospective multicenter institutional review board-approved, HIPAA-compliant protocol. B-mode Breast Imaging Reporting and Data System (BI-RADS) features and assessments were recorded. SW elastographic evaluation (mean, maximum, and minimum elasticity of stiffest portion of mass and surrounding tissue; lesion-to-fat elasticity ratio; ratio of SW elastographic-to-B-mode lesion diameter or area; SW elastographic lesion shape and homogeneity) was performed. Qualitative color SW elastographic stiffness was assessed independently. Nine hundred thirty-nine masses were analyzable; 102 BI-RADS category 2 masses were assumed to be benign; reference standard was available for 837 category 3 or higher lesions. Considering BI-RADS category 4a or higher as test positive for malignancy, effect of SW elastographic features on area under the receiver operating characteristic curve (AUC), sensitivity, and specificity after reclassifying category 3 and 4a masses was determined., Results: Median participant age was 50 years; 289 of 939 (30.8%) masses were malignant (median mass size, 12 mm). B-mode BI-RADS AUC was 0.950; eight of 303 (2.6%) BI-RADS category 3 masses, 18 of 193 (9.3%) category 4a lesions, 41 of 97 (42%) category 4b lesions, 42 of 57 (74%) category 4c lesions, and 180 of 187 (96.3%) category 5 lesions were malignant. By using visual color stiffness to selectively upgrade category 3 and lack of stiffness to downgrade category 4a masses, specificity improved from 61.1% (397 of 650) to 78.5% (510 of 650) (P<.001); AUC increased to 0.962 (P=.005). Oval shape on SW elastographic images and quantitative maximum elasticity of 80 kPa (5.2 m/sec) or less improved specificity (69.4% [451 of 650] and 77.4% [503 of 650], P<.001 for both), without significant improvement in sensitivity or AUC., Conclusion: Adding SW elastographic features to BI-RADS feature analysis improved specificity of breast US mass assessment without loss of sensitivity., (© RSNA, 2012)

Purpose: This prospective study evaluates whether sonoelastography can improve B-mode ultrasonographic sizing of breast tumors. Precise measuring is important for effective therapy planning for breast cancer patients., Materials and Methods: The size of 100 surgically excised breast lesions (92 patients: 77 malignant, 23 benign) was compared to preoperative measurements. Lesions were imaged with both ultrasonographic techniques in identical planes. The largest sizes measured with each modality were compared to the largest histopathological measurements. The interobserver variability was also computed from measurements made by two examiners assessing identical planes., Results: Both ultrasonographic measuring techniques underestimate lesion size. The sonoelastography measurements were within ± 5 mm of the histological size in 70.1 % of malignant lesions, and the B-mode measurements in 57.1 % of cases. Sonoelastography leads to more accurate measurements of 13.0 % of cases (statistically not significant). A total of 22 lesions were also imaged by a second examiner. Sonoelastography had 27.3 % less interobserver variability (examiners agreed in 36.4 % of sonoelastography and in 9.1 % of B-mode results)., Conclusion: In this study there is no significant advantage of sonoelastography, although a tendency is apparent. The low interobserver variability also favors sonoelastography for preoperative diagnostics, since it may be less dependent on the observer than conventional B-mode imaging. The results of this prospective study require validation in a prospective multicenter study with larger case numbers., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: This prospective study aimed to compare sonoelastography, B-mode ultrasonography, and mammography in terms of their ability to distinguish benign from malignant breast lesions. We also assessed how the diagnostic value of sonoelastography differs between palpable and clinically occult lesions., Materials and Methods: Evaluation revealed a total of 97 lesions (66 benign; 31 malignant) without histological confirmation at the time of the initial examination. The sensitivity, specificity, positive (PPV) and negative predictive value (NPV) as well as efficiency were calculated. These parameters were separately assessed for palpable lesions and for non-palpable lesions. We subsequently compared these results., Results: Sonography had a sensitivity of 97% and a specificity of 82% (PPV: 71 %, NPV: 98%, efficiency: 87%). For mammography, the respective figures were 84% and 89% (PPV: 79%, NPV: 92%, efficiency: 88%). Sonoelastography had a sensitivity of 71% and a specificity of 48% (PPV: 39%, NPV: 78%, efficiency: 56%). The combination of sonography and sonoelastography yielded a sensitivity of 100% and a specificity of 38% (PPV: 43%, NPV: 100%, efficiency: 58%). The sensitivity and specificity were not statistically different between the groups of palpable and non-palpable lesions., Conclusion: Sonoelastography is easily performed and not very time-consuming. Used by itself, the method is not more efficacious than alternative techniques. When used in conjunction with B-mode ultrasonography, the latter's sensitivity was increased, albeit at the expense of specificity., (© Georg Thieme Verlag KG Stuttgart · New York.)