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Background Both temporal changes in imaging characteristics of lymphadenopathy on US scans after COVID-19 vaccination and expected duration of radiologically evident lymphadenopathy remain uncertain. Purpose To longitudinally evaluate COVID-19 vaccine-associated lymphadenopathy on axillary US scans at various time intervals in both messenger (mRNA) and vector vaccine recipients. Materials and Methods This prospective cohort study was conducted between March 2021 and January 2022. The participants were asymptomatic women without breast cancer who had received COVID-19 vaccination. Serial follow-up US was performed in women with lymphadenopathy. The following variables were assessed: cortical thickness, number of lymph nodes, morphologic characteristics, and Doppler signal. Temporal changes in cortical thickness and number of lymph nodes during follow-up were assessed using a linear mixed model. Results Ninety-one women with lymphadenopathy in the vaccinated arm had undergone a total of 215 serial US examinations (mean age, 44 years ± 13 [SD]). Fifty-one participants had received a vector vaccine (ChAdOx1 nCoV-19 vaccine) and 40 had received an mRNA vaccine (BNT162b2 vaccine [

Background. Sentinel lymph node biopsy (SLNB) is currently the standard axillary staging procedure for clinically node-negative breast cancer. According to the ACOSOG Z0011 trial, axillary lymph node dissection (ALND) is now often omitted for clinically node-negative cT1-2 breast cancer patients undergoing breast-conserving surgery even if 1 or 2 metastatic lymph nodes (LN) are identified. It was shown that radiotherapy contributes to regional control of the axilla non-inferior to ALND even in the presence of metastatic LNs. Furthermore, LN metastasis has a limited role in planning adjuvant systemic therapy for hormone receptor-negative breast cancers, and also for hormone receptor-positive, HER2-negative breast cancer with increased use of genomic assays. SLNB is not without complications and omitting axillary staging operation could improve quality of life. Trial Design. In this multicenter, phase III randomized controlled trial including 9 study sites in South Korea, we plan to 1:1 randomize 1734 patients to either omit SLNB (Arm 1) or receive SLNB (Arm 2). Additional ALND can be performed according to the discretion of the surgeon according to the SLNB results. All patients must receive whole-breast irradiation ± tumor bed boost. The recommended upper margin of the radiation field is within 2cm of the humeral head. ClinicalTrials.gov identifier: NCT04303715. Eligibility. Inclusion criteria: women ≥19 years; cT1-2N0M0 unilateral invasive breast carcinoma; all molecular subtypes; clinically and radiologically tumor size ≤ 5cm; clinically- and ultrasonogram-negative axillary lymph nodes, or no tumor on core needle biopsy or fine needle aspiration cytology in case of suspicious lymph nodes; candidate for breast-conserving surgery with no restriction to radiotherapy and adequate systemic therapy. Exclusion criteria: history of any malignancy within 5 years (exception: thyroid cancer and well-treated skin cancer except melanoma); bilateral breast cancer; neoadjuvant chemotherapy; candidate for total mastectomy; male breast cancer. Specific Aims. Primary objective is to test the hypothesis that omitting SLNB for breast cancer is non-inferior to axillary staging operation in terms of 5-year disease-free survival. Secondary objectives are to compare overall survival, distant metastasis-free survival, locoregional recurrence, quality of life assessment, and DFS and axillary recurrence according to molecular subtypes. Statistical Methods. With an expected 5-year DFS of 86% for Arm 2, Arm 1(SLNB omission) will be assessed with a non-inferiority limit of 5% and hazard ratio of 1.4, power 80%, and significance level of 5%, where 224 events are required. The calculated sample size is 780 per study arm, resulting in a total of 1,734 patients assuming a 10% drop-out rate. Present Accrual and Target Accrual. The first patient was randomized on September 15, 2020. As of July 9, 2021, 480 patients have been randomized. Target accrual of 1734 patients is expected to be complete by April 2023, with the primary endpoint analysis expected in 2028. Citation Format: Han-Byoel Lee, Ji Gwang Jung, Jung Min Chang, Ji Hyun Chang, Woo Kyung Moon, Kyung Hwan Shin, Il Yong Chung, Seok Jin Nam, Eun-Kyu Kim, Seeyoun Lee, Seho Park, Woo Sung Lim, Yongsik Jung, Wonshik Han. The NAUTILUS trial (No Axillary sUrgical Treatment In clinically Lymph node negative patients after UltraSonography): A prospective multicenter randomized phase III trial (NCT04303715) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT1-04-02.

Purpose To develop a prediction model incorporating clinicopathological information, US, and MRI to diagnose axillary lymph node (LN) metastasis with acceptable false negative rate (FNR) in patients with early stage, clinically node-negative breast cancers. Methods In this single center retrospective study, the inclusion criteria comprised women with clinical T1 or T2 and N0 breast cancers who underwent preoperative US and MRI between January 2017 and July 2018. Patients were temporally divided into the development and validation cohorts. Clinicopathological information, US, and MRI findings were collected. Two prediction models (US model and combined US and MRI model) were created using logistic regression analysis from the development cohort. FNRs of the two models were compared using the McNemar test. Results A total of 964 women comprised the development (603 women, 54 ± 11 years) and validation (361 women, 53 ± 10 years) cohorts with 107 (18%) and 77 (21%) axillary LN metastases in each cohort, respectively. The US model consisted of tumor size and morphology of LN on US. The combined US and MRI model consisted of asymmetry of LN number, long diameter of LN, tumor type, and multiplicity of breast cancers on MRI, in addition to tumor size and morphology of LN on US. The combined model showed significantly lower FNR than the US model in both development (5% vs. 32%, P P

Background Background parenchymal enhancement (BPE) is a known risk factor for breast cancer. However, studies on the association between BPE and second breast cancer risk are still lacking. Purpose To investigate whether BPE at surveillance breast MRI is associated with subsequent second breast cancer risk in women with a personal history of breast cancer. Materials and Methods A retrospective search of the imaging database of an academic medical center identified consecutive surveillance breast MRI examinations performed between January 2008 and December 2017 in women who underwent surgery for primary breast cancer and had no prior diagnosis of second breast cancer. BPE at surveillance breast MRI was qualitatively assessed using a four-category classification of minimal, mild, moderate, or marked. Future second breast cancer was defined as ipsilateral breast tumor recurrence or contralateral breast cancer diagnosed at least 1 year after each surveillance breast MRI examination. Factors associated with future second breast cancer risk were evaluated using the multivariable Fine-Gray subdistribution hazard model. Results Among the 2668 women (mean age at baseline surveillance breast MRI, 49 years ± 8 [SD]), 109 developed a second breast cancer (49 ipsilateral, 58 contralateral, and two ipsilateral and contralateral) at a median follow-up of 5.8 years. Mild, moderate, or marked BPE at surveillance breast MRI (hazard ratio [HR], 2.1 [95% CI: 1.4, 3.1]

BACKGROUND There is increasing interest in noncontrast-enhanced MRI due to safety concerns for gadolinium contrast agents. PURPOSE To investigate the clinical feasibility of MR-based conductivity imaging for breast cancer detection and lesion differentiation. STUDY TYPE Prospective. SUBJECTS One hundred and ten women, with 112 known cancers and 17 benign lesions (biopsy-proven), scheduled for preoperative MRI. FIELD STRENGTH/SEQUENCE Non-fat-suppressed T2-weighted turbo spin-echo sequence (T2WI), dynamic contrast-enhanced MRI and diffusion-weighted imaging (DWI) at 3T. ASSESSMENT Cancer detectability on each imaging modality was qualitatively evaluated on a per-breast basis: the conductivity maps derived from T2WI were independently reviewed by three radiologists (R1-R3). T2WI, DWI, and pre-operative digital mammography were independently reviewed by three other radiologists (R4-R6). Conductivity and apparent diffusion coefficient (ADC) measurements (mean, minimum, and maximum) were performed for 112 cancers and 17 benign lesions independently by two radiologists (R1 and R2). Tumor size was measured from surgical specimens. STATISTICAL TESTS Cancer detection rates were compared using generalized estimating equations. Multivariable logistic regression analysis was performed to identify factors associated with cancer detectability. Discriminating ability of conductivity and ADC was evaluated by using the areas under the receiver operating characteristic curve (AUC). RESULTS Conductivity imaging showed lower cancer detection rates (20%-32%) compared to T2WI (62%-71%), DWI (85%-90%), and mammography (79%-88%) (all P

To investigate clinical and imaging features associated with a high nodal burden (≥ 3 metastatic lymph nodes [LNs]) and compare diagnostic performance of US and MRI in patients with invasive lobular carcinoma (ILC) and invasive ductal carcinoma (IDC). Retrospective search revealed 239 patients with ILC and 999 with IDC who underwent preoperative US and MRI between January 2016 and June 2019. Patients with ILC were propensity-score-matched with patients with IDC. Univariate and multivariate logistic regression analyses were performed to determine factors associated with ≥ 3 metastatic LNs. 412 patients (206 ILC and 206 IDC) were evaluated. Of all patients with ILC, 27.2% (56/206) were node-positive and 7.8% (16/206) showed a high nodal burden. In multivariate analysis, the clinical N stage was the only independent factor associated with a high nodal burden in patients with IDC (odds ratio [OR] 6.24; 95% confidence interval [CI] 1.57–24.73; P = 0.009), but not in patients with ILC. Increased cortical thickness with loss of fatty hilum on US was associated with a high nodal burden in patients with ILC (OR 58.40; 95% CI 5.09–669.71; P = 0.001) and IDC (OR 24.14; 95% CI 3.52–165.37; P = 0.001), while suspicious LN findings at MRI were independently associated with a high nodal burden in ILC only (OR 13.94; 95% CI 2.61–74.39; P = 0.002). In patients with ILC, MRI findings of suspicious LNs were helpful to predict a high nodal disease burden.

Background Few studies have compared abbreviated breast MRI with full-protocol MRI in women with a personal history of breast cancer (PHBC), and they have not adjusted for confounding variables. Purpose To compare abbreviated breast MRI with full-protocol MRI in women with PHBC by using propensity score matching to adjust for confounding variables. Materials and Methods In this single-center retrospective study, women with PHBC who underwent full-protocol MRI (January 2008-August 2017) or abbreviated MRI (September 2017-April 2019) were identified. With use of a propensity score-matched cohort, screening performances were compared between the two MRI groups with the McNemar test or a propensity score-adjusted generalized estimating equation. The coprimary analyses were sensitivity and specificity. The secondary analyses were the cancer detection rate, interval cancer rate, positive predictive value for biopsies performed (PPV3), and Breast Imaging Reporting and Data System (BI-RADS) category 3 short-term follow-up rate. Results There were 726 women allocated to each MRI group (mean age ± SD, 50 years ± 8 for both groups). Abbreviated MRI and full-protocol MRI showed comparable sensitivity (15 of 15 cancers [100%; 95% CI: 78, 100] vs nine of 13 cancers [69%; 95% CI: 39, 91], respectively

Background Little is known regarding findings at imaging associated with survival in patients with luminal breast cancer treated with neoadjuvant chemotherapy (NAC). Purpose To determine the relationship between imaging (MRI, US, and mammography) and clinical-pathologic variables in predicting distant metastasis-free survival (DMFS) and overall survival (OS) in patients with luminal breast cancer treated with NAC. Materials and Methods In this retrospective study, consecutive women with luminal breast cancer who underwent NAC followed by surgery were identified from the breast cancer registries of two hospitals. Women from one hospital between January 2003 and July 2015 were classified into the development cohort, and women from the other hospital between January 2007 and July 2015 were classified into the validation cohort. MRI scans, US scans, and mammograms before and after NAC (hereafter, referred to as pre- and post-NAC, respectively) and clinical-pathologic data were reviewed. Peritumoral edema was defined as the water-like high signal intensity surrounding the tumor on T2-weighted MRI scans. The prediction model was developed in the development cohort by using Cox regression and then tested in the validation cohort. Results The development cohort consisted of 318 women (68 distant metastases, 54 deaths) and the validation cohort consisted of 165 women (37 distant metastases, 14 deaths) (median age, 46 years in both cohorts). Post-NAC MRI peritumoral edema, age younger than 40 years, clinical N2 or N3, and lymphovascular invasion were associated with worse DMFS (all

To conduct a simulation study to determine whether artificial intelligence (AI)-aided mammography reading can reduce unnecessary recalls while maintaining cancer detection ability in women recalled after mammography screening.A retrospective reader study was performed by screening mammographies of 793 women (mean age ± standard deviation, 50 ± 9 years) recalled to obtain supplemental mammographic views regarding screening mammography-detected abnormalities between January 2016 and December 2019 at two screening centers. Initial screening mammography examinations were interpreted by three dedicated breast radiologists sequentially, case by case, with and without AI aid, in a single session. The area under the receiver operating characteristic curve (AUC), sensitivity, specificity, and recall rate for breast cancer diagnosis were obtained and compared between the two reading modes.Fifty-four mammograms with cancer (35 invasive cancers and 19 ductal carcinomas in situ) and 739 mammograms with benign or negative findings were included. The reader-averaged AUC improved after AI aid, from 0.79 (95% confidence interval [CI], 0.74-0.85) to 0.89 (95% CI, 0.85-0.94) (AI-aided reading reduced the number of recalls and improved the diagnostic performance in our simulation using women initially recalled for supplemental mammographic views after mammography screening.

Objective To compare the performance of simulated abbreviated breast MRI (AB-MRI) and full diagnostic (FD)-MRI in distinguishing between benign and malignant lesions detected by MRI and investigate the features of discrepant lesions of the two protocols. Materials and Methods An AB-MRI set with single first postcontrast images was retrospectively obtained from an FD-MRI cohort of 111 lesions (34 malignant, 77 benign) detected by contralateral breast MRI in 111 women (mean age, 49.8. ± 9.8; range, 28–75 years) with recently diagnosed breast cancer. Five blinded readers independently classified the likelihood of malignancy using Breast Imaging Reporting and Data System assessments. McNemar tests and area under the receiver operating characteristic curve (AUC) analyses were performed. The imaging and pathologic features of the discrepant lesions of the two protocols were analyzed. Results The sensitivity of AB-MRI for lesion characterization tended to be lower than that of FD-MRI for all readers (58.8–82.4% vs. 79.4–100%), although the findings of only two readers were significantly different (p < 0.05). The specificity of AB-MRI for lesion characterization was higher than that of FD-MRI for 80% of readers (39.0–74.0% vs. 19.5–45.5%, p ≤ 0.001). The AUC of AB-MRI was comparable to that of FD-MRI for all readers (p > 0.05). Fifteen percent (5/34) of the cancers were false-negatives on AB-MRI. More suspicious margins or internal enhancement on the delayed phase images were related to the discrepancies. Conclusion The overall performance of AB-MRI was similar to that of FD-MRI in distinguishing between benign and malignant lesions. AB-MRI showed lower sensitivity and higher specificity than FD-MRI, as 15% of the cancers were misclassified compared to FD-MRI.

OBJECTIVE To compare the utility and diagnostic performance of automated breast ultrasound system (ABUS) with that of hand-held ultrasound (HHUS) in evaluating pure non-mass enhancement (NME) lesions on breast magnetic resonance imaging (MRI). MATERIALS AND METHODS One hundred twenty-six consecutive MRI-visible pure NME lesions of 122 patients with breast cancer were assessed from April 2016 to March 2017. Two radiologists reviewed the preoperative breast MRI, ABUS, and HHUS images along with mammography (MG) findings. The NME correlation rate and diagnostic performance of ABUS were compared with that of HHUS, and the imaging features associated with ABUS visibility were analyzed. RESULTS Among 126 pure NME lesions, 100 (79.4%) were malignant and 26 (20.6%) were benign. The overall correlation rate was 87.3% (110/126) in ABUS and 92.9% (117/126) in HHUS. The sensitivity and specificity were 87% and 50% for ABUS and 92% and 42.3% for HHUS, respectively, with no significant differences (p = 0.180 and 0.727, respectively). Malignant NME was more frequently visualized than benign NME lesions on ABUS (93% vs. 65.4%, p = 0.001). Significant factors associated with the visibility of ABUS were the size of NME lesions on MRI (p < 0.001), their distribution pattern (p < 0.001), and microcalcifications on MG (p = 0.027). CONCLUSION ABUS evaluation of pure NME lesions on MRI in patients with breast cancer is a useful technique with high visibility, especially in malignant lesions. The diagnostic performance of ABUS was comparable with that of conventional HHUS in evaluating NME lesions.

Axillary lymph node (LN) metastasis is the most important predictor of overall recurrence and survival in patients with breast cancer, and accurate assessment of axillary LN involvement is an essential component in staging breast cancer. Axillary management in patients with breast cancer has become much less invasive and individualized with the introduction of sentinel LN biopsy (SLNB). Emerging evidence indicates that axillary LN dissection may be avoided in selected patients with node-positive as well as node-negative cancer. Thus, assessment of nodal disease burden to guide multidisciplinary treatment decision making is now considered to be a critical role of axillary imaging and can be achieved with axillary US, MRI, and US-guided biopsy. For the node-positive patients treated with neoadjuvant chemotherapy, restaging of the axilla with US and MRI and targeted axillary dissection in addition to SLNB is highly recommended to minimize the false-negative rate of SLNB. Efforts continue to develop prediction models that incorporate imaging features to predict nodal disease burden and to select proper candidates for SLNB. As methods of axillary nodal evaluation evolve, breast radiologists and surgeons must work closely to maximize the potential role of imaging and to provide the most optimized treatment for patients.

Accurate prediction of pathologic complete response (pCR) in breast cancer using magnetic resonance imaging (MRI) and ultrasound (US)-guided biopsy may aid in selecting patients who forego surgery for breast cancer. We evaluated the accuracy of US-guided biopsy aided by MRI in predicting pCR in the breast after neoadjuvant chemotherapy (NAC). After completion of NAC, 40 patients with near pCR (either tumor size ≤ 0.5 cm or lesion-to-background signal enhancement ratio (L-to-B SER) ≤ 1.6 on MRI) and no diffused residual microcalcifications were prospectively enrolled at a single institution. US-guided multiple core needle biopsy (CNB) or vacuum-assisted biopsy (VAB) of the tumor bed, followed by standard surgical excision, was performed. Matched biopsy and surgical specimens were compared to assess pCR. The negative predictive value (NPV), accuracy, and false-negative rate (FNR) were analyzed. pCR was confirmed in 27 (67.5%) surgical specimens. Preoperative biopsy had an NPV, accuracy, and FNR of 87.1%, 90.0%, and 30.8%, respectively. NPV for hormone receptor-negative and hormone receptor-positive tumors were 83.3% and 100%, respectively. Obtaining at least 5 biopsy cores based on tumor size ≤ 0.5 cm and an L-to-B SER of ≤ 1.6 on MRI (27 patients) resulted in 100% NPV and accuracy. No differences in accuracy were noted between CNB and VAB (90% vs. 90%). Investigation using stringent MRI criteria and ultrasound-guided biopsy could accurately predict patients with pCR after NAC. A larger prospective clinical trial evaluating the clinical safety of breast surgery omission after NAC in selected patients will be conducted based on these findings.

OBJECTIVE To evaluate the clinical utility of ultrafast dynamic contrast-enhanced (DCE)-MRI compared to conventional DCE-MRI by studying lesion conspicuity and size according to the level of background parenchymal enhancement (BPE). MATERIALS AND METHODS This study included 360 women (median age, 54 years; range, 26-82 years) with 361 who had undergone breast MRI, including both ultrafast and conventional DCE-MRI before surgery, between January and December 2017. Conspicuity was evaluated using a five-point score. Size was measured as the single maximal diameter. The Wilcoxon signed-rank test was used to compare median conspicuity score. To identify factors associated with conspicuity, multivariable logistic regression was performed. Absolute agreement between size at MRI and histopathologic examination was assessed using the intraclass correlation coefficient (ICC). RESULTS The median conspicuity scores were 5 at both scans, but the interquartile ranges were significantly different (5-5 at ultrafast vs. 4-5 at conventional, p < 0.001). Premenopausal status (odds ratio [OR] = 2.2, p = 0.048), non-mass enhancement (OR = 4.1, p = 0.001), moderate to marked BPE (OR = 7.5, p < 0.001), and shorter time to enhancement (OR = 0.9, p = 0.043) were independently associated with better conspicuity at ultrafast scans. Tumor size agreement between MRI and histopathologic examination was similar for both scans (ICC = 0.66 for ultrafast vs. 0.63 for conventional). CONCLUSION Ultrafast DCE-MRI could improve lesion conspicuity compared to conventional DCE-MRI, especially in women with premenopausal status, non-mass enhancement, moderate to marked BPE or short time to enhancement.

Purpose: To investigate the combined use of blood-based 3-protein signature and breast ultrasound (US) for validating US detected lesions.Methods: From July 2011 to April 2020, women who underwent whole-breast US within at least 6 months from sampling period were retrospectively included. Blood-based 3-protein signature (Mastocheck®) value and US findings were evaluated. Following outcome measures were compared between US alone and the combination of Mastocheck® value with US: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), area under the receiver operating characteristic curve (AUC), and biopsy rate. Results: Among the 237 women included, 59 (24.9%) were healthy individuals and 178 (75.1%) cancer patients. Mean size of cancers was 1.2±0.8 cm. Median value of Mastocheck® was significantly different between non-malignant (-0.24, interquartile range [IQR], -0.48, -0.03) and malignant lesions (0.55, IQR, -0.03, 1.42) (P < .001). Utilizing Mastocheck® value with US increased the AUC from 0.67 (95% confidence interval [CI], 0.61, 0.73) to 0.81 (95% CI: 0.75, 0.88; P < .001), specificity from 35.6% (95% CI: 23.4, 47.8) to 64.4% (95% CI: 52.2, 76.6; P < .001) without loss in sensitivity. PPV was increased from 82.2% (95% CI: 77.1, 87.3) to 89.3% (95% CI: 85.0, 93.6; P < .001), and biopsy rate was significantly decreased from 79.3% (188/237) to 72.1% (171/237) (P < .001). Consistent improvements in specificity, PPV, and AUC were observed in asymptomatic women and in those with normal/benign mammographic findings. Conclusion: Mastocheck® is an effective tool that can be used with US to improve diagnostic specificity and reduce false-positive findings and unnecessary biopsies.

This study aimed to evaluate the imaging and pathological findings in axillary lymph nodes in patients with breast cancer who received concurrent ipsilateral coronavirus disease 2019 (COVID-19) vaccination. Of the 19 women with breast cancer who received concurrent COVID-19 vaccination shot in the arm ipsilateral to breast cancer, axillary lymphadenopathy was observed in 84.2% (16 of 19) of patients on ultrasound (US) and 71.4% (10 of 14) of patients on magnetic resonance imaging (MRI), and 21.0% (4 of 19) of patients were diagnosed with metastasis. Abnormal US and MRI findings of cortical thickening, effacement of the fatty hilum, round shape, and asymmetry in the number or size relative to the contralateral side were noted in more than half of the non-metastatic and metastatic lymph nodes; however, statistical significance was not noted. Axillary lymphadenopathy is commonly observed in patients with breast cancer who receive concurrent ipsilateral COVID-19 vaccination without specific differential imaging features. Thus, understanding the limitations of axillary imaging and cautious interpretation is necessary to avoid overestimation or underestimation of the axillary disease burden.

Background Following sentinel lymph node biopsy (SLNB), the axillary recurrence rate is very low although SLNB has a false-negative rate of 5–10%. In the ACOSOG Z0011 trial, non-sentinel positive-lymph nodes were found in more than 20% of the axillary dissection group; the SLNB only group did not have a higher axillary recurrence rate. These findings raised questions about the direct therapeutic effect of the SLNB. SLNB has post-surgical complications including lymphedema. Considering advances in imaging modalities and adjuvant therapies, the role of SLNB in early breast cancer needs to be re-evaluated. Methods The NAUTILUS trial is a prospective multicenter randomized controlled trial involving clinical stage T1–2 and N0 breast cancer patients receiving breast-conserving surgery. Axillary ultrasound is mandatory before surgery with predefined imaging criteria for inclusion. Ultrasound-guided core needle biopsy or needle aspiration of a suspicious node is allowed. Patients will be randomized (1:1) into the no-SLNB (test) and SLNB (control) groups. A total of 1734 patients are needed, considering a 5% non-inferiority margin, 5% significance level, 80% statistical power, and 10% dropout rate. All patients in the two groups will receive ipsilateral whole-breast radiation according to a predefined protocol. The primary endpoint of this trial is the 5-year invasive disease-free survival. The secondary endpoints are overall survival, distant metastasis-free survival, axillary recurrence rate, and quality of life of the patients. Discussion This trial will provide important evidence on the oncological safety of the omission of SLNB for early breast cancer patients undergoing breast-conserving surgery and receiving whole-breast radiation, especially when the axillary lymph node is not suspicious during preoperative axillary ultrasound. Trial registration ClinicalTrials.gov, NCT04303715. Registered on March 11, 2020.

To investigate the correlations between ultrasonographic morphological characteristics quantitatively assessed using a deep learning-based computer-aided diagnostic system (DL-CAD) and histopathologic features of breast cancer. This retrospective study included 282 women with invasive breast cancer (

Low specificity and operator dependency are the main problems of breast ultrasound (US) screening. We investigated the added value of deep learning-based computer-aided diagnosis (S-Detect) and shear wave elastography (SWE) to B-mode US for evaluation of breast masses detected by screening US. Between February 2018 and June 2019, B-mode US, S-Detect, and SWE were prospectively obtained for 156 screening US-detected breast masses in 146 women before undergoing US-guided biopsy. S-Detect was applied for the representative B-mode US image, and quantitative elasticity was measured for SWE. Breast Imaging Reporting and Data System final assessment category was assigned for the datasets of B-mode US alone, B-mode US plus S-Detect, and B-mode US plus SWE by 3 radiologists with varied experience in breast imaging. Area under the receiver operator characteristics curve (AUC), sensitivity, and specificity for the 3 datasets were compared using Delong's method and McNemar test. Of 156 masses, 10 (6%) were malignant and 146 (94%) were benign. Compared to B-mode US alone, the addition of S-Detect increased the specificity from 8%–9% to 31%–71% and the AUC from 0.541–0.545 to 0.658–0.803 in all radiologists (All P

Background Breast density at mammography is an established risk factor for breast cancer, but it cannot be used to distinguish between glandular and fibrous tissue. Purpose To evaluate the association between the glandular tissue component (GTC) at screening breast US and the risk of future breast cancer in women with dense breasts and the association between the GTC and lobular involution. Materials and Methods Screening breast US examinations performed in women with no prior history of breast cancer and with dense breasts with negative findings from mammography from January 2012 to December 2015 were retrospectively identified. The GTC was reported as being minimal, mild, moderate, or marked at the time of the US examination. In women who had benign breast biopsy results, the degree of lobular involution in normal background tissue was categorized as not present, mild, moderate, or complete. The GTC-related breast cancer risk in women with a cancer diagnosis or follow-up after 6 months was estimated by using Cox proportional hazards regression. Cumulative logistic regression was used to evaluate the association between the GTC and lobular involution. Results Among 8483 women (mean age, 49 years ± 8 [standard deviation]), 137 developed breast cancer over a median follow-up time of 5.3 years. Compared with a minimal or mild GTC, a moderate or marked GTC was associated with an increased cancer risk (hazard ratio, 1.5; 95% CI: 1.05, 2.1; P = .03) after adjusting for age and breast density. The GTC had an inverse association with lobular involution; women with no, mild, or moderate involution had greater odds (odds ratios of 4.9 [95% CI: 1.5, 16.6], 2.6 [95% CI: 0.95, 7.2], and 1.8 [95% CI: 0.7, 4.6], respectively) of a moderate or marked GTC than those with complete involution (P = .004). Conclusion The glandular tissue component was independently associated with the future breast cancer risk in women with dense breasts and reflects the lobular involution. It should be considered for risk stratification during screening breast US. © RSNA, 2021 Online supplemental material is available for this article.

Background In patients who are expected to achieve axillary pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC), omission of axillary lymph node (LN) dissection could prevent morbidity and complications. Purpose To develop a clinical model to predict residual axillary LN metastasis in patients with clinically node-positive breast cancer after NAC by using MRI and US. Materials and Methods In this retrospective study, women with clinically node-positive breast cancer who were treated with NAC following surgery between January 2015 and September 2017 were included. The patients were randomly assigned to a test and validation set (7:3 ratio). Univariable and multivariable logistic regression analyses were performed to evaluate the independent predictors of residual axillary LN metastasis in the test set. A prediction risk score was developed based on the odds ratios from the multivariable analysis and validated in both sets. Results A total of 408 women were included (mean age ± standard deviation, 47.9 years ± 9.6). The axillary pCR rate was 56.6% (231 of 408). Independent predictors of residual axillary LN metastasis were clinical stage N2 or N3, presence of axillary lymphadenopathy at US after NAC, tumor size reduction less than 50% at MRI, Ki-67 negativity, hormone receptor positivity, and human epidermal growth factor receptor 2 negativity (all, P < .05). In a model using these predictors, the area under the receiver operating characteristic curve in the test and validation sets was 0.84 (95% confidence interval: 0.79, 0.88) and 0.78 (95% confidence interval: 0.70, 0.87), respectively. When the patients had a simplified risk score of 1, the false-negative rates ranged between 5%-10%. Conclusion A prediction model incorporating nodal status stage, US finding, MRI response, and molecular receptor status shows good diagnostic performance for residual axillary lymph node metastasis after neoadjuvant chemotherapy in patients with clinically node-positive breast cancer. © RSNA, 2019 Online supplemental material is available for this article. See also the editorial by Whitman in this issue.

Background There is an increasing need to develop a more accurate prediction model for pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC) in breast cancer. Purpose To develop a nomogram based on MRI and clinical-pathologic variables to predict pCR. Materials and Methods In this single-center retrospective study, consecutive women with stage II-III breast cancer who underwent NAC followed by surgery between January 2011 and December 2017 were considered for inclusion. The women were divided into a development cohort between January 2011 and September 2015 and a validation cohort between October 2015 and December 2017. Clinical-pathologic data were collected, and mammograms and MRI scans obtained before and after NAC were analyzed. Logistic regression analyses were performed to identify independent variables associated with pCR in the development cohort from which the nomogram was created. Nomogram performance was assessed with the area under the receiver operating characteristic curve (AUC) and calibration slope. Results A total of 359 women (mean age, 49 years ± 10 [standard deviation]) were in the development cohort and 351 (49 years ± 10) in the validation cohort. Hormone receptor negativity (odds ratio [OR], 3.1; 95% CI: 1.4, 7.1

Objective The aim of this study was to investigate the usefulness of staging chest-CT in terms of diagnostic yield and false-referral rate in patients with operable breast cancer. Materials and methods This study was approved by the institutional review border. In this retrospective study, we reviewed patients who underwent staging chest-CT between January 2014 and June 2016. Reference standard was defined as a combination of pathology and radiologic tumor changes in accordance with primary tumor or metastatic lesions and stability during the 12-month follow-up period. We calculated diagnostic yield and false-referral rates stratified by pathologic stage. The important ancillary findings of staging chest-CT were also recorded. Results A total of 1,342 patients were included in this study. Of these, four patients (0.3%; 4/1342) had true pulmonary metastasis. Diagnostic yields of stage I, II, III disease were 0.0% (0/521), 0.3% (2/693), and 1.6% (2/128), respectively. The overall false-referral rate was 4.6% (62/1342); false-referral rates of stage I, II, and III disease were 5.0% (26/521), 3.8% (26/693), and 7.8% (10/128), respectively. No occult thoracic metastasis occurred within 12 months of staging chest-CT. Nineteen patients showed significant ancillary findings besides lung metastasis, including primary lung cancer (n = 9). The overall diagnostic yield of ancillary findings was 1.7% (23 of 1342). Conclusions The incidence of pulmonary metastasis was near zero for pathologic stages I/II and slightly higher (although still low; 1.6%). for stage III. Considering its low diagnostic yield and substantial false-referral rates, staging chest-CT might not be useful in patients with operable breast cancer.

Background Digital breast tomosynthesis (DBT) with or without digital mammography (DM) is the primary method of breast cancer screening. However, the sufficiency of DBT screening for women at average risk and the need for supplemental whole-breast US needs further investigation. Purpose To evaluate the added value of supplemental US screening following combined DM/DBT. Materials and Methods A retrospective database search identified consecutive asymptomatic women who underwent DM/DBT and radiologist-performed screening breast US simultaneously between March 2016 and December 2018. The cancer detection rate (CDR) per 1000 screening examinations, sensitivity, specificity, and abnormal interpretation rate of DM/DBT and DM/DBT combined with US were compared. Results A total of 1003 women (mean age, 56 years ± 8.6 [standard deviation]) were included. Among them, 12 cancers (mean invasive tumor size, 14 mm; range, 6-33 mm) were diagnosed. With DM/DBT and DM/DBT combined with US, the CDRs were 9.0 per 1000 screening examinations (nine of 1003 women; 95% CI: 4.1, 17) and 12 per 1000 screening examinations (12 of 1003 women; 95% CI: 6.2, 21), respectively, and the abnormal interpretation rates were 7.8% (78 of 1003 women; 95% CI: 6.2, 9.6) and 24% (243 of 1003 women; 95% CI: 22, 27). In women with negative findings at DM/DBT, supplementary US yielded a CDR of 3.2 per 1000 examinations (three of 925 women; 95% CI: 0.7, 9.4), sensitivity of 100% (three of three women; 95% CI: 29, 100), specificity of 82% (760 of 922 women; 95% CI: 80, 85), and abnormal interpretation rate of 18% (165 of 925 women; 95% CI: 15, 21). The three additional US-detected cancers were identified in women with dense breasts; no benefit was observed in women with nondense breasts. Conclusion The addition of breast US to digital mammography and digital breast tomosynthesis yielded an additional 0.7-9.4 cancers per 1000 women at average risk, with a substantial increase in the abnormal interpretation rate. © RSNA, 2021

A major limitation of screening breast ultrasound (US) is a substantial number of false-positive biopsy. This study aimed to develop a deep learning-based computer-aided diagnosis (DL-CAD)-based diagnostic model to improve the differential diagnosis of screening US-detected breast masses and reduce false-positive diagnoses. In this multicenter retrospective study, a diagnostic model was developed based on US images combined with information obtained from the DL-CAD software for patients with breast masses detected using screening US; the data were obtained from two hospitals (development set: 299 imaging studies in 2015). Quantitative morphologic features were obtained from the DL-CAD software, and the clinical findings were collected. Multivariable logistic regression analysis was performed to establish a DL-CAD-based nomogram, and the model was externally validated using data collected from 164 imaging studies conducted between 2018 and 2019 at another hospital. Among the quantitative morphologic features extracted from DL-CAD, a higher irregular shape score (P = .018) and lower parallel orientation score (P = .007) were associated with malignancy. The nomogram incorporating the DL-CAD-based quantitative features, radiologists’ Breast Imaging Reporting and Data Systems (BI-RADS) final assessment (P = .014), and patient age (P P P P = .317 in the development cohort; each 100% in the validation cohort). In conclusion, the proposed model showed good performance for differentiating screening US-detected breast masses, thus demonstrating a potential to reduce unnecessary biopsies.