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Purpose: We evaluated the diagnostic performance of elastography and tissue quantification using acoustic radiation force impulse (ARFI) technology for differential diagnosis of breast masses.Materials and Methods: There were 161 mass lesions. First, lesion correspondence on ARFI elastographic images to those on the B-mode images was evaluated: no findings on ARFI images (pattern 1), lesions that were bright inside (pattern 2), lesions that were dark inside (pattern 4), lesions that contained both bright and dark areas (pattern 3). In addition, pattern 4 was subdivided into 4a (dark area same as B-mode lesion) and 4b (dark area larger than lesion). Next, shear wave velocity (SWV) was measured using virtual touch tissue quantification.Results: There were 13 pattern 1 lesions and five pattern 2 lesions; all of these lesions were benign, whereas all pattern 4b lesions (n = 43) were malignant. When the value of 3.59 m/s was chosen as the cutoff value, the combination of elastography and tissue quantification showed 91 % (83-91) sensitivity, 93 % (65-70) specificity, and 92 % (148-161) accuracy.Conclusion: The combination of elastography and tissue quantification is thought to be a promising ultrasound technique for differential diagnosis of breast-mass lesions. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to perform the phantom experiment and demonstrate the clinical usefulness of tissue quantification using a linear array transducer and acoustic radiation force impulse (ARFI) technology.Materials and Methods: For the phantom study, the commercially available Elasticity QA Phantom Model 049 was used. First, we measured the shear wave velocity (m/s) for the four spheres and the background of the phantom. Then, the shear wave velocity at nine sites was measured, with the region of interest being moved gradually from a shallow region (3 mm) to a deeper region (38 mm). For the clinical study, the shear wave velocities of 15 solid breast mass lesions were measured.Results: The phantom study confirmed the feasibility of quantitative determination of the degree of tissue hardness. Dispersion of the measured values tended to be somewhat increased for the depths of 3 mm and 38 mm. The mean shear wave velocity was 2.07-2.93 m/s for five benign lesions, whereas higher shear wave velocities (n = 2) (7.15, 7.44 m/s) or "X.XX" (unmeasurable state) (n = 7) were found for malignant lesions other than mucinous carcinoma (2.44 m/s).Conclusion: ARFI tissue quantification is a potentially promising ultrasonographic technique for diagnosing breast lesions. [ABSTRACT FROM AUTHOR]

Background: Power Doppler ultrasonography (US) is used in addition to B-mode US as a tool for the differential diagnosis between benign and malignant lesions. However, there are few data showing how useful power Doppler US is for BI-RADS category assessment. Purpose: To assess how much power Doppler US contributed to increasing the category diagnosis from Breast Imaging Reporting and Data System (ACR BI-RADS(®)-US) category 3 to category 4. Material and Methods: A total of 2426 patients (age range 16-91 years, mean 52 years) who underwent B-mode and power Doppler breast US using a linear 10-MHz transducer were analyzed. We devised integrated US category classification (BI-RADS-Integral) based on BI-RADS descriptors and vascularity. Masses with a circumscribed margin, parallel orientation, and negative vascularity on power Doppler US were defined as category 3. Irregular-shaped masses with a spiculated margin or echogenic halo were defined as category 5. Masses with one of the four suspicious findings (no circumscribed margin, no parallel orientation, microcalcifications, and positive vascularity) were defined as category 4a, and masses with two or more suspicious findings were defined as category 4b. Results: There were 98 breast cancer cases, and the average sizes of invasive and non-invasive cancers were 15 mm and 18 mm, respectively. The frequency of breast cancer according to category was: 0.4% (3/714) of the category 3 cases, 2.7% (7/256) in category 4a, 64% (47/73) in category 4b, and 100% (41/41) in category 5. Among the cases with a category 4a mass lesion, there were 183 lesions whose category diagnosis had been raised from category 3 to category 4a based on the Doppler blood flow findings alone, and 3 (1.6%) of those lesions were breast cancer. All three of them were ductal carcinoma in situ (DCIS) cases. When the cut-off point was placed between category 3 and category 4, BI-RADS-Integral and BI-RADS-US without power Doppler had a sensitivity of 96.9% and 93.9%, respectively, specificity of 72.1% and 90.4%, respectively, and accuracy of 74.4% and 90.7%, respectively. Conclusion: The presence of Doppler blood flow increases the malignancy pick-up rate, but at the expense of a significant decrease in specificity and diagnostic accuracy and an increase in biopsy rate. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to investigate the clinical usefulness of acoustic radiation force impulse (ARFI) imaging for the differential diagnosis of breast lesions.Materials and Methods: We studied 40 solid mass lesions from a total of 40 patients (age range 29-67 years, mean 50 years). There were 18 benign lesions and 22 malignant tumors. ARFI imaging was performed using Virtual Touch tissue imaging. We examined the possibility of lesions seen on B-mode images being visually confirmed on ARFI images. When the lesion was visually confirmed, the lesions that were bright or dark inside were classified into patterns 1 and patterns 3, respectively. The lesions that failed to be visually confirmed were classified as pattern 2.Results: There were 3 pattern 1 lesions and 7 pattern 2 lesions; all of these lesions were benign. The remaining 8 benign lesions and 22 malignant lesions were determined to be pattern 3. The negative predictive value was 100%.Conclusion: ARFI imaging is a potentially promising ultrasonographic technique for the differential diagnosis of breast lesions, particularly complicated cysts without a cystic component on B-mode images. [ABSTRACT FROM AUTHOR]

Purpose: The aims of this study were to investigate the visualization rate for the mammary gland under the nipple with automated breast ultrasonography (US) and to compare the detectability of breast lesions under the nipple with automated breast imaging and handheld US imaging.Materials and Methods: A total of 60 patients underwent automated breast US (ABVS; Siemens Medical Solutions, Mountain View, CA, USA) and handheld US. The scans of the four segments of the breast included sequential scans in the upper-outer (C), lower-outer (D), lower-inner (B), and upper-inner (A) regions.Results: The visualization rates for the mammary gland under the nipple were 72% (86/120 breasts) in A-scanning, 84% (101/120) in B-scanning, 78% (93/120) in C-scanning, and 80% (96/120) in D-scanning. Interscanning mode differences were statistically significant only for A-scanning and B-scanning (P = 0.02). Eventually, 98% (117/120 breasts) of the breasts examined were rated as "visualized." In 14 of the 15 patients with breast lesions under the nipple, the lesions were detectable with handheld US and the ABVS. In the other patient, the lesion was not detectable on handheld US but was detected on ABVS imaging.Conclusion: ABVS imaging is by no means inferior to handheld US for detecting breast lesions under the nipple. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to clarify the frequency of malignancy and the histopathological characteristics of the lesions in patients undergoing magnetic resonance imaging (MRI)-guided vacuum-assisted biopsy (VAB).Materials and Methods: A retrospective review of 100 consecutive patients with 102 lesions who had undergone MRI-guided VAB was performed. The biopsies were performed on a 1.5-T MR scanner using a commercially available biopsy system. None of the lesions seen with MRI could be detected by mammography or second-look ultrasonography.Results: The average lesion sizes of the focus, mass, and nonmass lesions before the biopsy were 4.5, 8.2, and 21 mm, respectively. Twelve patients (12%) had lesions located in the deep portion of the breast, close to the pectoral muscle. The biopsy was successfully performed without important side effects in all patients. Histopathological findings were invasive ductal carcinoma in 6 (6%), in situ carcinoma in 28 (27%), and high-risk and benign in 68 (67%). Two high-risk lesions were upgraded to ductal carcinoma in situ (DCIS), and three DCIS lesions were upgraded to invasive ductal carcinoma at surgical excision.Conclusion: The high rate of DCIS might be a unique feature among Japanese women. However, MRI-guided VAB is necessary for MRI-only visible suspicious lesions in Japan. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to assess the scanning technique for covering the whole breast using a commercially available automated breast ultrasonography (US) system.Materials and Methods: A total of 40 patients in the supine position underwent automated breast US (ABVS: Siemens Medical Solutions, Mountain View, CA, USA) and hand-held US. The scanning included sequential scans in the upper-outer, lower-outer, lower-inner, and upper-inner regions. After scanning all four segments of each breast using ABVS, hand-held US was performed in all the patients. The detectability of the lesions using the ABVS technique compared with that using the handheld US was evaluated. The average scanning time was compared between any two of the three examiners with various lengths of experience in breast US.Results: In all, 61 lesions were detected by hand-held US. The average size of the lesions was 7.7 mm (range 2.5-26.0 mm). The number of detected lesions by ABVS was consistent with those found by hand-held US in each patient. The average total scanning time for each examiner using ABVS was 10.9, 11.1, and 11.5 min, respectively. No significant difference was found in the total scanning time between any two of the three examiners.Conclusion: The four-scans technique for the major segments of the breast is thought to be an operator-independent, feasible method for performing automated breast US. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to assess the efficacy of single-voxel (1)H magnetic resonance spectroscopy (MRS) at 1.5 T to evaluate early responses to neoadjuvant chemotherapy after the first treatment in breast cancer patients and to compare it to measurements of apparent diffusion coefficient (ADC) values derived from diffusion-weighted magnetic resonance imaging (MRI).Materials and Methods: Nine patients with breast cancer who were scheduled to receive neoadjuvant chemotherapy were recruited. MR examination after the first cycle was scheduled for a few days before the administration of the second dose.Results: Two patients were excluded from the study because their regimen was changed after the first cycle. MRS before chemotherapy demonstrated the presence of choline (Cho) at 3.22-3.23 ppm in six cases and at 3.27 ppm in one case. Diffusion-weighted MRI before chemotherapy demonstrated a localized high-signal lesion in all cases. The change of the integral value of Cho after the first cycle of chemotherapy showed a positive correlation with the change in lesion size (r = 0.91, P = 0.01), whereas no correlation was observed between the change of ADC values after the first cycle and the change in lesion size (r = 0.45, P = 0.32).Conclusion: MRS after the first cycle may be more sensitive to diffusion-weighted MRI to predict the pathological response. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to determine the accuracy of measuring preoperative cancer extent using automated breast ultrasonography (US).Materials and Methods: This retrospective study consisted of 40 patients with histopathologically confirmed breast cancer. All of the patients underwent automated breast US (ABVS; Siemens Medical Solutions, Mountain View, CA, USA) on the day before the surgery. The sizes of the lesions on US were measured on coronal multiplanar reconstruction images using the ABVS workstation. Histopathological measurement of tumor size included not only the invasive foci but also any in situ component and was used as the gold standard. The discrepancy of the tumor extent between automated breast US and the histological examination was calculated.Results: Automated breast US enabled visualization of the breast carcinomas in all patients. The mean size of the lesions on US was 12 mm (range 4-62 mm). The histopathological diagnosis was ductal carcinoma in situ (DCIS) in seven patients and invasive ductal carcinoma in 33 patients (18 without an intraductal component, 15 with an intraductal component). Lesions ranged in diameter from 4 to 65 mm (mean 16 mm). The accuracy of determination of the tumor extent with a deviation in length of <2 cm was 98% (39/40).Conclusion: Automated breast US is thought to be useful for evaluating tumor extent preoperatively. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to enhance the diagnostic accuracy of contrast-enhanced breast magnetic resonance imaging (MRI) using gadobutrol for differentiating benign breast lesions from malignant ones. Moreover, this study sought to address the limitations of current imaging techniques and criteria based on the Breast Imaging Reporting and Data System (BI-RADS)., Materials and Methods: In a multicenter retrospective study conducted in Japan, 200 women were included, comprising 100 with benign lesions and 100 with malignant lesions, all classified under BI-RADS categories 3 and 4. The MRI protocol included 3D fast gradient echo T1- weighted images with fat suppression, with gadobutrol as the contrast agent. The analysis involved evaluating patient and lesion characteristics, including age, size, location, fibroglandular tissue, background parenchymal enhancement (BPE), signal intensity, and the findings of mass and non-mass enhancement. In this study, univariate and multivariate logistic regression analyses were performed, along with decision tree analysis, to identify significant predictors for the classification of lesions., Results: Differences in lesion characteristics were identified, which may influence malignancy risk. The multivariate logistic regression model revealed age, lesion location, shape, and signal intensity as significant predictors of malignancy. Decision tree analysis identified additional diagnostic factors, including lesion margin and BPE level. The decision tree models demonstrated high diagnostic accuracy, with the logistic regression model showing an area under the curve of 0.925 for masses and 0.829 for non-mass enhancements., Conclusion: This study underscores the importance of integrating patient age, lesion location, and BPE level into the BI-RADS criteria to improve the differentiation between benign and malignant breast lesions. This approach could minimize unnecessary biopsies and enhance clinical decision-making in breast cancer diagnostics, highlighting the effectiveness of gadobutrol in breast MRI evaluations., (© 2024. The Author(s).)

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.

Objectives: Shear wave elastography (SWE) is increasingly used in breast cancer diagnostics. However, large, prospective, multicenter data evaluating the reliability of SWE is missing. We evaluated the intra- and interobserver reliability of SWE in patients with breast lesions categorized as BIRADS 3 or 4., Methods: We used data of 1288 women at 12 institutions in 7 countries with breast lesions categorized as BIRADS 3 to 4 who underwent conventional B-mode ultrasound and SWE. 1243 (96.5%) women had three repetitive conventional B-mode ultrasounds as well as SWE measurements performed by a board-certified senior physician. 375 of 1288 (29.1%) women received an additional ultrasound examination with B-mode and SWE by a second physician. Intraclass correlation coefficients (ICC) were calculated to examine intra- and interobserver reliability., Results: ICC for intraobserver reliability showed an excellent correlation with ICC >0.9, while interobserver reliability was moderate with ICC of 0.7. There were no clinically significant differences in intraobserver reliability when SWE was performed in lesions categorized as BI-RADS 3 or 4 as well as in histopathologically benign or malignant lesions., Conclusion: Reliability of additional SWE was evaluated on a study cohort consisting of 1288 breast lesions categorized as BI-RADS 3 and 4. SWE shows an excellent intraobserver reliability and a moderate interobserver reliability in the evaluation of solid breast masses., (© 2023 The Authors. Journal of Ultrasound in Medicine published by Wiley Periodicals LLC on behalf of American Institute of Ultrasound in Medicine.)

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.)

Purpose: We evaluated the diagnostic performance of the texture features of dynamic contrast-enhanced (DCE) MRI for breast cancer diagnosis in which the discriminator was optimized, so that the specificity was maximized via the restriction of the negative predictive value (NPV) to greater than 98%., Methods: Histologically proven benign and malignant mass lesions of DCE MRI were enrolled retrospectively. Training and testing sets consist of 166 masses (49 benign, 117 malignant) and 50 masses (15 benign, 35 malignant), respectively. Lesions were classified via MRI review by a radiologist into 4 shape types: smooth (S-type, 34 masses in training set and 8 masses in testing set), irregular without rim-enhancement (I-type, 60 in training and 14 in testing), irregular with rim-enhancement (R-type, 56 in training and 22 in testing), and spicula (16 in training and 6 in testing). Spicula were immediately classified as malignant. For the remaining masses, 298 texture features were calculated using a parametric map of DCE MRI in 3D mass regions. Masses were classified into malignant or benign using two thresholds on a feature pair. On the training set, several feature pairs and their thresholds were selected and optimized for each mass shape type to maximize specificity with the restriction of NPV > 98%. NPV and specificity were computed using the testing set by comparison with histopathologic results and averaged on the selected feature pairs., Results: In the training set, 27, 12, and 15 texture feature pairs are selected for S-type, I-type, and R-type masses, respectively, and thresholds are determined. In the testing set, average NPV and specificity using the selected texture features were 99.0% and 45.2%, respectively, compared to the NPV (85.7%) and specificity (40.0%) in visually assessed MRI category-based diagnosis., Conclusion: We, therefore, suggest that the NPV of our texture-based features method described performs similarly to or greater than the NPV of the MRI category-based diagnosis.

Objectives: AI-based algorithms for medical image analysis showed comparable performance to human image readers. However, in practice, diagnoses are made using multiple imaging modalities alongside other data sources. We determined the importance of this multi-modal information and compared the diagnostic performance of routine breast cancer diagnosis to breast ultrasound interpretations by humans or AI-based algorithms., Methods: Patients were recruited as part of a multicenter trial (NCT02638935). The trial enrolled 1288 women undergoing routine breast cancer diagnosis (multi-modal imaging, demographic, and clinical information). Three physicians specialized in ultrasound diagnosis performed a second read of all ultrasound images. We used data from 11 of 12 study sites to develop two machine learning (ML) algorithms using unimodal information (ultrasound features generated by the ultrasound experts) to classify breast masses which were validated on the remaining study site. The same ML algorithms were subsequently developed and validated on multi-modal information (clinical and demographic information plus ultrasound features). We assessed performance using area under the curve (AUC)., Results: Of 1288 breast masses, 368 (28.6%) were histopathologically malignant. In the external validation set (n = 373), the performance of the two unimodal ultrasound ML algorithms (AUC 0.83 and 0.82) was commensurate with performance of the human ultrasound experts (AUC 0.82 to 0.84; p for all comparisons > 0.05). The multi-modal ultrasound ML algorithms performed significantly better (AUC 0.90 and 0.89) but were statistically inferior to routine breast cancer diagnosis (AUC 0.95, p for all comparisons ≤ 0.05)., Conclusions: The performance of humans and AI-based algorithms improves with multi-modal information., Key Points: • The performance of humans and AI-based algorithms improves with multi-modal information. • Multimodal AI-based algorithms do not necessarily outperform expert humans. • Unimodal AI-based algorithms do not represent optimal performance to classify breast masses., (© 2022. The Author(s).)

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.)

Overseas, the importance for breast MRI screening for high-risk groups has been shown. However, the evidence among Japanese population was lacking. Therefore, we collaborated with the "Study on clinical and genetic characterization of hereditary breast and ovarian cancer and improvement in prognosis using genetic information in Japan" group, as part of the Comprehensive Research Project on the Promotion of Cancer Control, Health and Labour Sciences Research, and have been conducting the study entitled, "Study of the usefulness of MRI surveillance of BRCA1/2 mutation carriers" since 2014. In addition, we found that in the Japanese population also, the pathological and imaging characteristics differ between BRCA1 and BRCA2 mutation carriers, like in non-Japanese populations by the several reports. In high-risk females, risk categories such as BRCA1 or BRCA2 mutation carriers are very important. Furthermore, in the future, the optimal surveillance modalities and examination intervals would also vary according to the age, thinness of the breast (constitution), breast density (individual differences on mammography), etc.; this would be "personalized surveillance", and quality-assured MRI examination is of the essence. This review will present clinical trial data of prospective MRI surveillance in Japan, and summarize the current status of breast cancer screening in high-risk Japanese women., (© 2020. The Japanese Breast Cancer Society.)

In April 2018, the national health insurance coverage of MRI-guided vacuum-assisted breast biopsy (VAB) was instituted with the application of the Japan Breast Cancer Society. Although MRI-guided VAB has been considered as a special procedure for a long time, having an access to this procedure should be recommended for facilities performing breast MRI as in Western countries. From now on, relevant societies should make efforts in data collection and quality control of MRI-guided VAB in Japan. We must avoid the following. To delay the early diagnosis of breast cancer in the judgment of an inaccurate indication, perform unnecessary biopsy due to overestimation of diagnosis, and reduce the success rate of MRI-guided VAB with immature techniques. This review explains the current status of MRI-guided VAB in Japan and shares procedure and biopsy data as a future reference from an experienced facility., (© 2020. The Japanese Breast Cancer Society.)

Background: The high concentration of gadolinium in gadobutrol, which is widely used in Japan, helps visualize signal enhancement of neoplastic lesions, however, there was concern that high T1 relaxivity could decrease the contrast between the lesion and the background mammary gland. We evaluate the effect of gadobutrol on background parenchymal enhancement (BPE) and differential diagnosis between benign and malignant lesions in dynamic MRI of the breast., Methods: Ninety-nine patients were enrolled prospectively. Measurements of the following signal intensities (SIs) were obtained: breast tissue on a pre-contrast image (SI pre ) and an early-phase image (SI early ); and the SIs of breast cancer on a pre-contrast image (SI pre-cancer ) and an early-phase image (SI early-cancer ). We calculated the BPE ratio, i.e., (SI early  - SI pre )/SI pre and the cancer/BPE ratio, i.e., (SI early-cancer  - SI pre-cancer )/(SI early on the affected side - SI pre on the affected side). These quantitative assessments were compared with the data from the recently published multicenter study (reference study without use of gadobutrol). In addition, two radiologists reinterpreted each of the MR images, and a third radiologist set the ROIs in the lesions and performed kinetic analysis as a Reader 3., Results: While there was no significant difference in the SI of breast cancer in the premenopausal patients between the two studies, that in postmenopausal patients was significantly higher in the present study than in the reference study (p = 0.002). Although there was no significant difference in the cancer/BPE ratio in the postmenopausal patients between the two studies, the cancer/BPE ratio in the premenopausal patients was significantly higher in the reference study than in the present study (p = 0.028). For differentiation between benign and malignant masses, the mass margin was found to be the most important term (p < 0.001). According to the data of Reader 3, visual washout was observed in all 18 patients in whom the interpretation was changed from "plateau" to "washout"., Conclusions: Gadobutrol may decrease the contrast between breast cancer and background parenchyma in premenopausal patients, and it may have a characteristic that "washout" does not easily occur, leading to "plateau" in patients with breast cancer.

Preventing the escape of hazardous genes from genetically modified organisms (GMOs) into the environment is one of the most important issues in biotechnology research. Various strategies were developed to create "genetic firewalls" that prevent the leakage of GMOs; however, they were not specially designed to prevent the escape of genes. To address this issue, we developed amino acid (AA)-swapped genetic codes orthogonal to the standard genetic code, namely SL (Ser and Leu were swapped) and SLA genetic codes (Ser, Leu, and Ala were swapped). From mRNAs encoded by the AA-swapped genetic codes, functional proteins were only synthesized in translation systems featuring the corresponding genetic codes. These results clearly demonstrated the orthogonality of the AA-swapped genetic codes against the standard genetic code and their potential to function as "genetic firewalls for genes". Furthermore, we propose "a codon-bypass strategy" to develop a GMO with an AA-swapped genetic code.

Immune attacks are key issues for cell transplantation. To assess the safety and the immune reactions after iPS cells-derived retinal pigment epithelium (iPS-RPE) transplantation, we transplanted HLA homozygote iPS-RPE cells established at an iPS bank in HLA-matched patients with exudative age-related macular degeneration. In addition, local steroids without immunosuppressive medications were administered. We monitored immune rejections by routine ocular examinations as well as by lymphocytes-graft cells immune reaction (LGIR) tests using graft RPE and the patient's blood cells. In all five of the cases that underwent iPS-RPE transplantation, the presence of graft cells was indicated by clumps or an area of increased pigmentation at 6 months, which became stable with no further abnormal growth in the graft during the 1-year observation period. Adverse events observed included corneal erosion, epiretinal membrane, retinal edema due to epiretinal membrane, elevated intraocular pressure, endophthalmitis, and mild immune rejection in the eye. In the one case exhibiting positive LGIR tests along with a slight fluid recurrence, we administrated local steroid therapy that subsequently resolved the suspected immune attacks. Although the cell delivery strategy must be further optimized, the present results suggest that it is possible to achieve stable survival and safety of iPS-RPE cell transplantation for a year.

Background: To compare the breast cancer detection performance in digital mammograms of a panel of three unaided human readers (HR) versus a stand-alone artificial intelligence (AI)-based Transpara system in a population of Japanese women., Methods: The subjects were 310 Japanese female outpatients who underwent digital mammographic examinations between January 2018 and October 2018. A panel of three HR provided a Breast Imaging Reporting and Data System (BI-RADS) score, and Transpara system provided an interactive decision support score and an examination-based cancer likelihood score. The area under the receiver operating characteristic curve (AUC), sensitivity, and specificity were compared under each of reading conditions., Results: The AUC was higher for human readers than with stand-alone Transpara system (human readers 0.816; Transpara system 0.706; difference 0.11; P < 0.001). The sensitivity of the unaided HR for diagnosis was 89% and specificity was 86%. The sensitivity of stand-alone Transpara system for cutoff scores of 4 and 7 were 93% and 85%, and specificities were 45% and 67%, respectively., Conclusions: Although the diagnostic performance of Transpara system was statistically lower than that of HR, the recent advances in AI algorithms are expected to reduce the difference between computers and human experts in detecting breast cancer.

Purpose: The tumor microenvironment is related to the metabolism of cancer cells and local immune reactions. Previous studies have established TILs could be a significant prognostic factor, especially for triple-negative breast cancers (TNBC) and human epithelial growth factor receptor 2 (HER2)-positive breast cancers. We explore the association between metabolic information on PET/MRI with TILs in TNBC and HER2-positive breast cancer., Method: We retrospectively reviewed the cases of 55 women with triple-negative or HER2-positive invasive ductal carcinomas who had undergone 18 F-FDG PET/MRI without neo-adjuvant treatment for pre-operative evaluation. FDG uptake was quantified as standardized uptake value (SUV) max. The existence of peritumoral edema on PET/MRI was also recorded. The TIL score of the breast cancers was defined histologically on the basis of the proportion of the area infiltrated by lymphocytes, and classified as low (<10 %), intermediate (10-50 %), and high (>50 %). The association between PET/MRI findings and TILs was assessed using Kruskal-Wallis test and Wilcoxon signed-rank test., Results: There were 14 high TIL, 20 intermediate TIL and 21 low TIL lesions. Higher values of SUVmax were found in the high and intermediate TIL group as compared to the low TIL group (P = 0.013). On the other hand, the lesions with peritumoral edema in the low TIL group tended to show high SUVmax (P = 0.014)., Conclusions: 18 F-FDG uptake on PET/MRI correlated with TIL levels in patients with TNBC and HER2-positive breast cancer. This finding suggests that preoperative PET/MRI may be useful as a non-invasive tool for guiding the treatment plan., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: There is no consensus on the appropriate surveillance for high-risk women with breast cancer in Japan. We investigated their imaging features and pathological characteristics to build a proper surveillance system for asymptomatic high-risk individuals in the future., Methods: We retrospectively reviewed 93 female (median age 43 years) BRCA1 and BRCA2 mutation carriers from our institutional clinical database from 2011 to 2017. The study population was composed of 112 breast cancers. Mammography and MRI were reviewed by examiners blinded to patients' clinical history. Final surgical or biopsy histopathology served as the reference standard in all the patients., Results: Fifty-nine breast cancers met selection criteria; of these, 30 were BRCA1-associated tumors, and 29 were BRCA2-associated tumors. Invasive ductal carcinoma was the most prevalent type in both BRCA1 and BRCA2. There were statistically significant differences in phenotype, nuclear grade, and Ki-67 labeling index between BRCA1 and BRCA2 mutation carriers. Additionally, imaging findings on mammography and MRI were statistically different. Tumors in BRCA2 carriers demonstrated mammographic calcifications more frequently, while those in BRCA1 carriers demonstrated a mass or architectural distortion (P < 0.001). Enhancement pattern on MRI also significantly differed between the two subgroups (P = 0.006). The size of MRI-detected lesions was statistically smaller than the size of those detected by other modalities (P = 0.004)., Conclusions: The imaging and histological characteristics of BRCA1/2 mutation carriers were consistent with other countries' studies. MRI-detected lesions were significantly smaller than lesions detected by non-MRI modality. All lesions in BRCA1 mutation carriers could be detected by MRI.

Purpose: To evaluate the effect of the menstrual cycle on BPE and cancer detectability in an Asian population., Material and Methods: 266 premenopausal patients with regular menstrual cycles from 24 centers were included, and 176 of them were diagnosed by pathology as having breast cancer. Thirty-five patients were examined in the menstrual phase (days 1-4), 105 in the proliferative phase (days 5-14), and 126 in the secretory phase (days 15-30). Measurement of the following signal intensities (SIs) were obtained: breast tissue on the unaffected side on a pre-contrast image (SI 1 ) and an early-phase image (SI 2 ); the SIs of breast tissue on the affected side on a pre-contrast image (SI 3 ) and an early-phase image (SI 4 ); and the SIs of breast cancer on a pre-contrast image (SI 5 ) and an early-phase image (SI 6 ). We calculated the BPE ratio, i.e., (SI 2 - SI 1 )/SI 1 and the cancer/background enhancement ratio (C/B) ratio, i.e., (SI 6 - SI 5 ) / (SI 4 - SI 3 ). The BPE was classified as minimal, mild, moderate, or marked, and the cancer detectability was classified as excellent, good, or poor independently by two radiologists., Results: The average C/B ratio was 20.1, 15.7, and 9.1 at the menstrual, proliferative, and secretory phases (p < 0.001). BPE was determined as moderate or marked in 0% and 5.4% at the menstrual phase, 10.3% and 11.0% at the proliferative phase, and 17.5% and 21.7% at the secretory phase by the two observers, respectively (p = 0.01, p = 0.01). The detectability of breast cancer was classified as poor in 0% and 0%, 1.4% and 13.0%, and 8.0% and 22.1% at the menstrual, proliferative, and secretory phases by the two observers, respectively (p = 0.07, p = 0.02)., Conclusion: The menstrual phase and the proliferative phase seem to be suitable for breast MRI of Asian women., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Purpose: To evaluate the feasibility of proposed integrated slice-by-slice shimming (iShim) for whole-body diffusion weighted imaging (WB-DWI) in comparison to conventional 3D shim in patients with breast cancer., Materials and Methods: Retrospective analysis of 116 consecutive patients (116 lesions) who underwent whole-body PET/MR using iShim (iShim group) were performed and compared with historical control of 103 patients (105 lesions) using 3D Shim (3D Shim group)., Results: As compared with dynamic contrast-enhanced (DCE) breast MRI, the apparent diffusion coefficient (ADC) value could not be determined for 15 (14%) of the 105 lesions of the 3D shim group and for 10 (9%) of the 116 lesions on iShim group. The intergroup difference failed to reach statistical significance (P = 0.1843). On the other hand, there was a significant difference in the frequencies of PET-positive and DWI-negative lesions between the 3D shim and iShim group (8.6% vs. 1.7%, respectively, P = 0.01942)., Conclusion: In regard to detectability of breast cancers by DWI, iShim may allow improved detectability as compared to conventional 3D shim.

Rationale and Objectives: We aimed to investigate the relationship between shear wave speed (SWS) of the lesion on preoperative breast ultrasonography (US) and disease-free survival of patients with primary operable invasive breast cancer., Materials and Methods: This retrospective study was approved by our Institutional Review Board. The requirement for informed consent was waived. A total of 195 consecutive newly diagnosed invasive breast cancer patients (age 33-83 years; mean 54.0 years) with preoperative breast US with SWS measurement of the lesion were identified. They underwent surgery between May 2012 and May 2013. SWS was measured at the center and three marginal zones in the main tumors, and the maximum value was used for analyses. For 35 patients who underwent primary systemic therapy (PST), the maximum SWS before PST was used. Cox proportional hazards modeling was used to identify the relationship between clinical-pathologic factors and disease-free survival., Results: Fourteen recurrences occurred at 6-47 months (mean 22.3 months) after surgery. On multivariate analysis, a positive history of PST (hazard ratio [HR] = 4.93; 95% confidence interval [CI]: 1.66, 14.70; P = .004), adjuvant chemotherapy (HR = 3.67; 95% CI: 1.11, 12.1; P = .033), and higher maximum SWS (HR = 1.55; 95% CI: 1.07, 2.23; P = .020) were associated with poorer disease-free survival., Conclusion: Higher maximum SWS on preoperative US, in addition to a positive history of PST and adjuvant chemotherapy, was significantly associated with poorer disease-free survival of patients with invasive breast cancer., (Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.)

Rationale and Objectives: We aimed to investigate the utility of problem-solving breast magnetic resonance imaging (MRI) for mammographic Breast Imaging Reporting and Data System (BI-RADS) categories 3 and 4 microcalcifications., Materials and Methods: Between January 1, 2010 and December 31, 2011, 138 women with 146 areas of categories 3 and 4 microcalcifications without sonographic correlates underwent breast MRI and had a stereotactic core biopsy using an 11-gauge needle or follow-up at least for 24 months. Positive predictive value (PPV), negative predictive value, sensitivity, and specificity were calculated on the basis of BI-RADS category, with categories 1-3 being considered benign and categories 4 and 5 being considered malignant., Results: Twenty-four cases (16.4%) were malignant (18 ductal carcinoma in situ, 6 invasive). MRI increased PPV and specificity from 43% to 68% and from 80% to 93% (P = .054 and .005) compared to mammography. Within 102 category 3 microcalcifications, 5 carcinomas were assessed correctly as category 4 by MRI. Within 44 category 4 microcalcifications, a correct diagnosis was made by MRI in 77% (34 of 44) as opposed to 43% (19 of 44) by mammography, and 80% (20 of 25) of unnecessary biopsies could have been avoided. Within the 24 carcinomas, 5 were negative at MRI. MRI-negative carcinomas have a significantly higher possibility of being low grade (ductal carcinoma in situ or invasive) (P = .0362)., Conclusions: Breast MRI has the potential to improve the diagnosis of category 3 or 4 microcalcifications and could alter indications for biopsy. Breast MRI could help predict the presence or absence of higher-grade carcinoma for category 3 or 4 microcalcifications., (Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare standardized uptake value (SUV) and apparent diffusion coefficient (ADC) values acquired using a PET/MRI scanner in breast cancer patients., Materials and Methods: Whole-body PET/MRI and breast PET/MRI were performed in 108 consecutive patients. Ninety-four patients who had a total of 100 breast cancers were analyzed. SUVmax and ADCmean acquired using breast PET/MRI were compared with pathologic prognostic factors., Results: All the lesions were visually detectable using PET and diffusion-weighted imaging (DWI) on breast PET/MRI; however, lesions were visually undetectable on whole-body DWI in 13 patients (13%) or on whole-body PET in 7 patients (7%). An analysis of ADCmean and SUVmax demonstrated a statistically significant correlation between whole-body imaging and breast imaging (rho = 0.613, p < 0.001 and rho = 0.928, p < 0.001, respectively). In a univariate analysis, SUVmax was significantly correlated with HER2 status (p < 0.001), Ki-67 (p = 0.014), tumor size (p = 0.0177), and nuclear grade (p = 0.0448). In multiple regression analysis, only tumor size (p = 0.00701) was shown to independently influence SUVmax., Conclusion: Prone breast imaging was more sensitive than whole-body PET/MRI for detection of breast cancers. Both SUVmax and ADCmean showed limited correlation with pathologic prognostic factors.

The present case is the first report in Japan in which a breast cancer was discovered as a result of prospective magnetic resonance imaging (MRI) screening study for BRCA1/2 mutation carriers who were free of breast or ovarian cancer. This case is significant and it verifies the importance of MRI screening in breast or ovarian cancer-free BRCA1/2 mutation carriers who do not exhibit positive mammographic or ultrasonographic findings.

Background Because of its small size, a focus in breast magnetic resonance imaging (MRI) must be evaluated on the basis of characteristics other than morphologic features. Patient-related factors including patient age, in conjunction with lesion-related factors, could be useful for decision-making. Purpose To assess the probability of malignant foci based on both lesion- and patient-related factors, and to propose a relevant decision-making method. Material and Methods Foci in our breast MRI database dating from April 2006 to June 2013 were retrospectively identified and analyzed. A Fisher's exact test or a Mann-Whitney U test were performed for univariate analyses, and factors that showed a significant association with outcome in the univariate analyses were subjected to multivariate analysis using a logistic regression model. A decision tree was then drawn using the significant predictors confirmed by multivariate analysis. Results In total, 184 foci (168 benign, 16 malignant) in 184 patients were analyzed in our study. The presence of a washout pattern and older age were found to be significant predictors of malignancy ( P < 0.0001; odds ratio [OR], 17.8; P = 0.021; OR, 1.1, respectively). The main decisive node on the decision tree was the presence of a washout pattern, followed by whether the patient's age was >63 years. Conclusion An enhancing focus showing a washout pattern, especially in older patients, may warrant immediate biopsy rather than short-interval follow-up.

Rationale and Objectives: This study aims to investigate the clinical significance of malignant non-mass enhancement (NME) descriptors in breast magnetic resonance images by assessing their correlation to the presence of invasion or lymph node metastasis., Materials and Methods: Three radiologists independently reviewed magnetic resonance images with malignant NMEs between January 2008 and December 2009. Distribution was assessed first, and then each of four internal enhancement patterns-clumped, clustered ring, branching, and hypointense area-was evaluated dichotomously (yes or no). Because clustered rings and hypointense areas were thought to be major structural elements of heterogeneous NMEs, they were also evaluated by integrating them into one collective descriptor we called the "heterogeneous structures." Chi-square test, Fisher exact test, or Student t test was used to analyze differences of variables by each reviewer. Positive predictive values (PPVs) of descriptors in predicting presence of invasion or lymph node metastasis were calculated. P < 0.05 was considered significant., Results: We included 131 malignant NMEs (76 in situ and 55 invasive) in 129 patients (two bilateral). All three observers' results showed clustered rings (PPVs 54.5%, 54.5%, 50.0%) (P = 0.0005, 0.038, 0.029) and hypointense areas (PPVs 63.6%, 61.5%, 73.9%) (P = 0.004, 0.024, 0.0006) to be significantly associated with invasion. When clustered rings and hypointense areas were integrated into heterogeneous structures, they were significantly associated with invasion (PPVs 54.3%, 53.3%, 51.8%) (P = 0.0003, 0.016, 0.003)., Conclusions: The NME descriptors clustered rings, hypoechoic areas, and heterogeneous structures, assessed collectively, were associated with invasive breast cancer., (Copyright © 2016 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate and compare the use of a newly introduced interpretation model for breast nonmass enhancement (NME, defined as an area of enhancement without a three-dimensional, space-occupying lesion) with the use of the standard interpretation method based on BI-RADS., Materials and Methods: Two expert and two less-experienced breast imaging radiologists performed reading sessions of 86 malignant and 64 benign NME lesions twice. First, radiologists characterized NME using BI-RADS descriptors and assessed the likelihood of malignancy and need for a biopsy. Second, the likelihood of malignancy and need for a biopsy were assessed with the use of the model, in which three-step characterization of morphological features were performed: (1) selection of distribution modifiers, (2) homogeneous vs. heterogeneous internal enhancement (IE) pattern, and (3) evaluation of presence of "clumped", "clustered ring enhancement (CRE)", and "branching" IE signs. Multireader-multicase receiver operating characteristic analysis was used to evaluate observers' performances. Univariate and multivariate logistic regression analyses were performed for morphology descriptors., Results: With use of the model, average Az of less-experienced radiologists (0.77-0.83; p=0.013) and average sensitivity of all radiologists (96.2-98.2%; p=0.007) improved significantly. NPV also improved but nonsignificantly (81.1-91.9%; p=0.055). Multivariate analyses of the second reading showed branching, clumped, and CRE signs to be significant predictors of malignancy in the results of 3, 2, and 2 readers, respectively., Conclusion: The three-step interpretation model for NME has the potential to improve less-experienced radiologists' performances, making them comparable to expert breast imagers., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: Some reports suggest that the rate of definitive diagnosis of malignant tumors, namely, the final diagnosis being revised to a higher stage, in patients diagnosed as having flat epithelial atypia (FEA) by percutaneous needle biopsy of the breast (PNB) is as low as 0-3 %. However, other reports suggest that the rate is as high as 10 % or more, bringing confusion on this issue. We examined the positive predictive value for malignancy in the patients diagnosed as having pure FEA and the patients' radiolopathological characteristics observed in our hospital., Methods: Of the patients who underwent PNB in our facility, those who were diagnosed as having pure FEA were recruited as the subjects of this study., Results: Of the 4,197 consecutive patients who underwent PNB, 44 (1.0 %) were diagnosed as having pure FEA following a re-examination. Among 44 cases, 39 cases were selected as the subjects of this study. Among the 39 patients, six patients were diagnosed as having malignant lesions, two of whom had invasive carcinoma of no special type (papillotubular type), one had tubular carcinoma, one had ductal carcinoma in situ (DCIS) of high nuclear grade, one had DCIS of intermediate nuclear grade, and one had DCIS of low nuclear grade. The diameters of 6 malignant lesions were 10-30 mm at ultrasonography (US) examination. Five of the 39 patients had contralateral breast cancer., Conclusion: The positive predictive value for malignancy of pure FEA was 15.7 %. The patients with pure FEA may make a follow up without an excisional biopsy when the lesion sizes less than 10 mm on US examination.

Purpose: To compare positive predictive values (PPVs) of linearly distributed nonmass enhancement (NME) with linear and branching patterns and to identify imaging characteristics of NME that would enable classification as Breast Imaging Reporting and Data System category 3 lesions., Materials and Methods: The institutional review board approved this retrospective study and waived the requirement to obtain informed consent. Reports of breast magnetic resonance (MR) examinations (n = 9453) that described NME were reviewed from examinations performed at the study institution from January 2008 to December 2011. NME with linear distribution was allocated to one of two subtypes: linear pattern (arrayed in a line) or branching pattern (with branches). The χ(2) test, Fisher exact test, or Student t test was performed for univariate analyses. Factors that showed a significant association with outcome at univariate analyses were assessed with multivariate analyses by using a logistic regression model. Interobserver agreement of the two subtypes between initial interpretation and the interpretation by two additional radiologists who were blinded to any clinical or pathologic information was evaluated with κ analysis., Results: Within the 156 linearly distributed NME lesions, the PPV of the branching pattern (71 of 95 lesions [75%]; 95% confidence interval [CI]: 66%, 84%) was significantly higher than that of the linear pattern (five of 61 lesions [8%]; 95% CI: 1%, 15%) (P < .0001). The PPV of linear pattern lesions smaller than 1 cm was 0% (0 of 30 lesions; 95% CI: 0%, 0%). At multivariate analysis, branching pattern and NME lesion size of 1 cm or greater were significant predictors of malignancy (P < .0001 [odds ratio: 21.6; 95% CI: 7.5, 62.2] and P = .015 [odds ratio: 5.8; 95% CI: 1.4, 24.0], respectively). Substantial interobserver agreement was obtained for differentiating the two subtypes, with κ values of 0.64 (95% CI: 0.51, 0.76), 0.70 (95% CI: 0.59, 0.82), and 0.64 (95% CI: 0.51, 0.76) between the initial interpreter and reviewer 1, the initial interpreter and reviewer 2, and reviewer 1 and reviewer 2, respectively., Conclusion: The branching pattern was a significantly stronger predictor of malignancy than was the linear pattern. NME lesions with a linear pattern that are smaller than 1 cm can be managed with follow-up.

Background: We assembled needed data on the prevalence and characteristics of BRCA1/2 in Japan., Materials and Methods: Our study of BRCA1/2 collected data at eight institutions in Japan on 320 individuals with a strong family history of breast cancer, according to the NCCN guidelines, by the end of March 2012., Results: Among 260 proband cases, 46 (17.7 %) were positive for BRCA1, and 35 (13.5 %) were BRCA2-positive. Therefore, the total pathological mutation rate was 30.7 %. Pathology data after breast surgery were obtained from 37 cases of BRCA1 mutation, 23 (62.2 %) of which were triple negative (TN). On the other hand, 29 cases (82.9 %) of BRCA2 mutations were Luminal type. The most prevalent BRCA1 mutation site was L63X, found in 10 families. L63X was reported previously by studies in Japan, and it may be a founder mutation. We found two cases of large deletion detected by multiplex ligation-dependent probe amplification. One was an entire deletion of exon 20 and the lacked exons 1-9. TN with a family history of ovarian cancer was 11/20 (55 %). TN under 40-year-old (y.o.) 15/23 (65.2 %) and TN with one or more breast cancers in family history 17/32 (53.1 %) showed higher incidences of BRCA1 mutation., Conclusion: Hereditary breast and ovarian cancer (HBOC) may have nearly the same prevalence in Japan as in the US or Europe. If TN cases are taken into account, the ratio of BRCA1 is higher. L63X may be one of the founder mutations in Japan. A nationwide database of HBOC is important to develop risk models for BRCA1/2 carriers in Japan.

The primary modality for breast cancer screening is mammography. Recent investigations, however, have indicated that an insufficient number of life-threatening cases have been detected by mammography while mammography can often results in a large number of overdiagnoses. To make breast cancer screening more effective, potential factors that influence screening efficacy need to be elucidated. Breast density is one of limiting factors for breast cancer detection using mammography. In this article, influence of breast density on breast screening is explained. Current topics related to breast density, objective assessment of breast density using applications, revision of breast composition classification in Breast Imaging-Reporting and Data System Mammography fifth edition, and legislative movement regarding breast density in the United States, are also mentioned in this review article.

Purpose: To demonstrate the noninferiority of gadobutrol-enhanced magnetic resonance imaging (MRI) compared with gadopentetate dimeglumine-enhanced MRI in Asian patients referred for contrast-enhanced imaging of the body or extremities., Materials and Methods: A multicenter, parallel-group comparison study of Asian adults referred for contrast-enhanced MRI were randomized (1:1) to either gadobutrol or gadopentetate dimeglumine. Lesions were assessed for three primary visualization variables: degree of contrast enhancement, border delineation, and internal morphology. Secondary efficacy variables included number of lesions detected, match of MRI diagnosis with final clinical diagnosis, and sensitivity and specificity for malignant lesion detection. Safety was monitored for 24 ± 4 hours after contrast agent administration., Results: A total of 363 patients received either gadobutrol (n = 168) or gadopentetate dimeglumine (n = 178). Mean total scores for three primary visualization variables were 9.39 and 9.34 for gadobutrol and gadopentetate dimeglumine, respectively. The proportion of patients with matched MRI and final diagnosis and sensitivity for malignant lesion detection was greater for unenhanced versus combined images (gadobutrol: 72.2% vs. 81.7%; gadopentetate dimeglumine: 76.2% vs. 82.2%, respectively). Both contrast agents were well tolerated., Conclusion: Gadobutrol (0.1 mmol/kg BW) was well tolerated and effective in Asian patients referred for contrast-enhanced MRI of the body or extremities., (© 2014 Wiley Periodicals, Inc.)