Lumpectomy without radiation for ductal carcinoma in situ of the breast: 20-year results from the ECOG-ACRIN E5194 study.

We report the 20-year rate of ipsilateral breast event (IBE) for patients with ductal carcinoma in situ (DCIS) treated with lumpectomy without radiation on a non-randomized prospective clinical trial. Patients were enrolled in cohort 1: low- or intermediate-grade DCIS, size ≤ 2.5 cm (n = 561); or cohort 2: high-grade DCIS, size ≤ 1 cm (n = 104). The Kaplan-Meier method was used to estimate time-to-event distributions. Cox proportional hazard methods were used to estimate hazard ratios (HRs) and tests for significance for event times. 561 patients were enrolled in cohort 1 and 104 in cohort 2. After central pathology review, 26% in cohort 1 were recategorized as high-grade and 26% in cohort 2 as low- or intermediate-grade. Mean DCIS size was similar at 7.5 mm in cohort 1 and 7.8 mm in cohort 2. Surgical margin was ≥3 mm in 96% of patients, and about 30% received tamoxifen. Median follow-up was 19.2 years. There were 104 IBEs, of which 54 (52%) were invasive. The IBE and invasive IBE rates increased in both cohorts up to 15 years, then plateaued. The 20-year IBE rates were 17.8% for cohort 1 and 28.7% for cohort 2 (p = 0.005), respectively. Invasive IBE occurred in 9.8% and 15.1% (p = 0.09), respectively. On multivariable analysis, IBE risk increased with size and was higher in cohort 2, but grade and margin width were not significantly associated with IBE. For patients with DCIS treated with excision without radiation, the rate of IBE increased with size and assigned cohort mostly in the first 15 years.

Breast Cancer Screening and Treatment Clinical Trials Updated for 2023.

There are many active or recently completed breast cancer screening and treatment trials in 2023 that have the potential to fundamentally change the way breast radiologists practice medicine. Breast cancer screening trials may provide evidence to support supplemental screening beyond mammography to include US, contrast-enhanced mammography, and breast MRI. Furthermore, there are multiple efforts to support risk-adaptive screening strategies that would personalize screening modalities, frequencies, and ages of initiation. For breast cancer treatment, aims to reduce overtreatment may provide nonsurgical treatment options for women with low-risk breast cancer. Breast radiologists must be familiar with the study designs, major inclusion and exclusion criteria, and principal endpoints in order to determine when and how the study results should influence clinical care. As multidisciplinary team members, breast radiologists will have major roles in the success or failure of these trials as they transition from research to actual clinical practice.

High-Temporal/High-Spatial Resolution Breast Magnetic Resonance Imaging Improves Diagnostic Accuracy Compared With Standard Breast Magnetic Resonance Imaging in Patients With High Background Parenchymal Enhancement.

PURPOSE: To compare breast magnetic resonance imaging (MRI) diagnostic performance using a standard high-spatial resolution protocol versus a simultaneous high-temporal/high-spatial resolution (HTHS) protocol in women with high levels of background parenchymal enhancement (BPE). MATERIALS AND METHODS: We conducted a retrospective study of contrast-enhanced breast MRIs performed at our institution before and after the introduction of the HTHS protocol. We compared diagnostic performance of the HTHS and standard protocol by comparing cancer detection rate (CDR) and positive predictive value of biopsy (PPV3) among women with high BPE (ie, marked or moderate). RESULTS: Among women with high BPE, the HTHS protocol demonstrated increased CDR (23.6 per 1,000 patients v 7.9 per 1,000 patients; P = 0. 013) and increased PPV3 (16.0% v 6.3%; P = .021) compared with the standard protocol. This corresponded to a 9.8% (95% CI, 1.29 to 18.3) decrease in the proportion of unnecessary biopsies among high-BPE patients and an additional cancer yield of 15.7 per 1,000 patients (95% CI, 1.3 to 18.3). CONCLUSION: Among women with high BPE, HTHS MRI improved diagnostic performance, leading to an additional cancer yield of 15.7 cancers per 1,000 women and concomitantly decreasing unnecessary biopsies by 9.8%. A multisite prospective trial is warranted to confirm these findings and to pave the way for more widespread clinical implementation.

Novel Machine Vision Image Guidance System Significantly Reduces Procedural Time and Radiation Exposure Compared With 2-dimensional Fluoroscopy-based Guidance in Pediatric Deformity Surgery.

BACKGROUND: Intraoperative 2-dimensional (2D) fluoroscopy imaging has been commonly adopted for guidance during complex pediatric spinal deformity correction. Despite the benefits, fluoroscopy imaging emits harmful ionizing radiation, which has been well-established to have deleterious effects on the surgeon and operating room staff. This study investigated the difference in intraoperative fluoroscopy time and radiation exposure during pediatric spine surgery between 2D fluoroscopy-based navigation and a novel machine vision navigation system [machine vision image guidance system (MvIGS)]. METHODS: This retrospective chart review was conducted at a pediatric hospital with patients who underwent posterior spinal fusion for spinal deformity correction from 2018 to 2021. Patient allocation to the navigation modality was determined by the date of their surgery and the date of implementation of the MvIGS. Both modalities were the standard of care. Intraoperative radiation exposure was collected from the fluoroscopy system reports. RESULTS: A total of 1442 pedicle screws were placed in 77 children: 714 using MvIGS and 728 using 2D fluoroscopy. There were no significant differences in the male-to-female ratio, age range, body mass index, distribution of spinal pathologies, number of levels operated on, types of levels operated on, and the number of pedicle screws implanted. Total intraoperative fluoroscopy time was significantly reduced in cases utilizing MvIGS (18.6 ± 6.3 s) compared with 2D fluoroscopy (58.5 ± 19.0 s) ( P < 0.001). This represents a relative reduction of 68%. Intraoperative radiation dose area product and cumulative air kerma were reduced by 66% (0.69 ± 0.62 vs 2.0 ± 2.1 Gycm 2 , P < 0.001) and 66% (3.4 ± 3.2 vs 9.9 ± 10.5 mGy, P < 0.001) respectively. The length of stay displayed a decreasing trend with MVIGS, and the operative time was significantly reduced in MvIGS compared with 2D fluoroscopy for an average of 63.6 minutes (294.5 ± 15.5 vs 358.1 ± 60.6 min, P < 0.001). CONCLUSION: In pediatric spinal deformity correction surgery, MvIGS was able to significantly reduce intraoperative fluoroscopy time, intraoperative radiation exposure, and total surgical time, compared with traditional fluoroscopy methods. MvIGS reduced the operative time by 63.6 minutes and reduced intraoperative radiation exposure by 66%, which may play an important role in reducing the risks to the surgeon and operating room staff associated with radiation in spinal surgery procedures. LEVEL OF EVIDENCE: Level III; retrospective comparative study.

Contrast-enhanced mammography in the assessment of residual disease after neoadjuvant treatment.

PURPOSE: To investigate the utility of contrast-enhanced mammography (CEM) as an alternative to breast MRI for the evaluation of residual disease after neoadjuvant treatment (NAT). METHODS: This prospective study enrolled consecutive women undergoing NAT for breast cancer from July 2017-July 2019. Breast MRI and CEM exams performed after completion of NAT were read independently by two breast radiologists. Residual disease and lesion size on MRI and CEM recombined (RI) and low-energy images (LEI) were compared. Histopathology was considered the reference standard. Statistical analysis was performed using McNemar's and Leisenring's tests. Multiple comparison adjustment was made using Bonferroni procedure. Lesion sizes were correlated using Kendall's tau coefficient. RESULTS: There were 110 participants with 115 breast cancers. Residual disease (invasive cancer or ductal carcinoma in situ) was detected in 83/115 (72%) lesions on pathology, 71/115 (62%) on MRI, 55/115 (48%) on CEM RI, and 75/115 (65%) on CEM LEI. When using multiple comparison adjustment, no significant differences were detected between MRI combined with CEM LEI and CEM RI combined with CEM LEI, in terms of accuracy (MRI: 77%, CEM: 72%; p ≥ 0.99), sensitivity (MRI: 88%, CEM: 81%; p ≥ 0.99), specificity (MRI: 47%, CEM: 50%; p ≥ 0.99), PPV (MRI: 81%, CEM: 81%; p ≥ 0.99), or NPV (MRI: 60%, CEM: 50%; p ≥ 0.99). Size correlation between pathology and both MRI combined with CEM LEI and CEM RI combined with CEM LEI was moderate: τ = 0. 36 vs 0.33 (p ≥ 0.99). CONCLUSION: Contrast-enhanced mammography is an acceptable alternative to breast MRI for the detection of residual disease after neoadjuvant treatment.

Association Between Surgery Preference and Receipt in Ductal Carcinoma In Situ After Breast Magnetic Resonance Imaging: An Ancillary Study of the ECOG-ACRIN Cancer Research Group (E4112).

Importance: Guiding treatment decisions for women with ductal carcinoma in situ (DCIS) requires understanding patient preferences and the influence of preoperative magnetic resonance imaging (MRI) and surgeon recommendation. Objective: To identify factors associated with surgery preference and surgery receipt among a prospective cohort of women with newly diagnosed DCIS. Design, Setting, and Participants: A prospective cohort study was conducted at 75 participating institutions, including community practices and academic centers, across the US between March 25, 2015, and April 27, 2016. Data were analyzed from August 2 to September 24, 2021. This was an ancillary study of the ECOG-ACRIN Cancer Research Group (E4112). Women with recently diagnosed unilateral DCIS who were eligible for wide local excision and had a diagnostic mammogram within 3 months of study registration were included. Participants who had documented surgery and completed the baseline patient-reported outcome questionnaires were included in this substudy. Exposures: Women received preoperative MRI and surgeon consultation and then underwent wide local excision or mastectomy. Participants will be followed up for recurrence and overall survival for 10 years from the date of surgery. Main Outcomes and Measures: Patient-reported outcome questionnaires assessed treatment goals and concerns and surgery preference before MRI and after MRI and surgeon consultation. Results: Of the 368 participants enrolled 316 (86%) were included in this substudy (median [range] age, 59.5 [34-87] years; 45 women [14%] were Black; 245 [78%] were White; and 26 [8%] were of other race). Pre-MRI, age (odds ratio [OR] per 5-year increment, 0.45; 95% CI, 0.26-0.80; P = .007) and the importance of keeping one's breast (OR, 0.48; 95% CI, 0.31-0.72; P < .001) vs removal of the breast for peace of mind (OR, 1.35; 95% CI, 1.04-1.76; P = .03) were associated with surgery preference for mastectomy. After MRI and surgeon consultation, MRI upstaging (48 of 316 [15%]) was associated with patient preference for mastectomy (OR, 8.09; 95% CI, 2.51-26.06; P < .001). The 2 variables with the highest ORs for initial receipt of mastectomy were MRI upstaging (OR, 12.08; 95% CI, 4.34-33.61; P < .001) and surgeon recommendation (OR, 4.85; 95% CI, 1.99-11.83; P < .001). Conclusions and Relevance: In this cohort study, change in patient preference for DCIS surgery and surgery received were responsive to MRI results and surgeon recommendation. These data highlight the importance of ensuring adequate information and ongoing communication about the clinical significance of MRI findings and the benefits and risks of available treatment options.

Identifying Food Parenting Practices From Comprehensive Home Environment Survey.

OBJECTIVE: Conducting exploratory factor analysis (EFA) with the existing home environment assessment-the Comprehensive Home Environment Survey (CHES), to identify scales related to food parenting practices. METHODS: Parents of 3- to 5-year-old children (n = 172) completed the CHES surveys. After selected items from CHES were categorized into food parenting practice constructs, EFA was used to identify potential subconstructs. Internal consistency and Spearman correlation analysis were also conducted. RESULTS: The EFAs identified 4 factors within the structure, 4 within coercive control, and 2 within autonomy support. CONCLUSIONS AND IMPLICATIONS: The results provided preliminary evidence and support that the CHES can be used to measure food parenting practices. The study was limited to a small sample of non-Hispanic White and highly educated participants, less identified items within autonomy support, and lower internal consistency for several identified factors. Confirmatory factor analysis in a larger and more diverse sample is needed for future research.

Patient-Reported Testing Burden of Breast Magnetic Resonance Imaging Among Women With Ductal Carcinoma In Situ: An Ancillary Study of the ECOG-ACRIN Cancer Research Group (E4112).

Importance: The use of magnetic resonance imaging (MRI) in pretreatment planning of ductal carcinoma in situ (DCIS) remains controversial. Understanding changes in short-term health-related quality of life associated with breast MRI would allow for a more complete comparative effectiveness assessment. Objective: To assess whether there are changes in patient-reported quality of life associated with breast MRI among women diagnosed with DCIS. Design, Setting, and Participants: This cohort study was a substudy of a nonrandomized clinical trial conducted at 75 participating US institutions from March 2015 to April 2016. Women recently diagnosed with unilateral DCIS who were eligible for wide local excision and had a diagnostic mammogram within 3 months of study registration were included. A total of 355 women met the eligibility criteria and underwent the study MRI. Data analysis was performed from June 3, 2020, to July 1, 2021. Exposures: Participants underwent bilateral breast MRI within 30 days of study registration and before surgery. Information on patient-reported testing burden for breast MRI was collected after MRI and before surgery. Main Outcomes and Measures: The primary outcome of this substudy was the patient-reported testing burden of breast MRI, measured by the Testing Morbidities Index (TMI) summated scale score. The TMI is a 7-item instrument that evaluates the temporary changes in quality of life associated with imaging before, during, and after the test (0 represents the worst possible, 100 the hypothetical ideal test experience). Results: Of the 355 women who met the eligibility criteria, 244 (69%) completed both questionnaires and were included in this analysis. The median age was 59 years (range, 34-85 years). The mean MRI TMI summated scale score was 85.9 (95% CI, 84.6-87.3). Of the 244 women, 142 (58%) experienced at least some fear and anxiety before the examination, and 120 women (49%) experienced fear and anxiety during the examination. A total of 156 women (64%) experienced pain or discomfort during the examination. In multivariable analyses, greater test-related burden was associated with higher levels of cancer worry (regression coefficient, -2.75; SE, 0.94; P = .004). Conclusions and Relevance: In this cohort study, a clinically meaningful breast MRI testing burden among women with DCIS was revealed that was significantly associated with cancer worry. Understanding the potential quality-of-life reduction associated with MRI, especially when used in combination with mammography, may allow development of targeted interventions to improve the patient experience.

Parenting Styles, Food Parenting Practices and Dietary Intakes of Preschoolers.

Previous evidence suggests that children's eating behaviors were largely influenced by the parent and home eating structure. This study examined the relationship between parenting styles (including authoritative, authoritarian, indulgent, and uninvolved), food parenting practices (within Structure, Coercive Control, and Autonomy Support constructs) and dietary intakes of preschoolers. Children aged 3-5 years and their parents were recruited from preschools/daycare centers and parents completed the surveys (n = 166). Dietary intakes were collected using the Harvard Service Food Frequency Questionnaire (HSFFQ), parenting style was assessed using the Parenting Dimensions Inventory-Short Version (PDI-S), and food parenting practices were measured using Comprehensive Home Environment Survey (CHES). The results showed that food parenting practices had a higher number of specific significant findings on children's nutrient and food group intakes than parenting styles. Correlation analyses showed positive parenting practices within Structure were significantly related to healthier children's intakes (e.g., vegetables, iron, and folate) and less unhealthy dietary intakes (e.g., sweets and total fats). Regression models show that children with authoritative parents consumed more fruits compared to children with authoritarian parents and indulgent parents. The results addressed the importance of parental influences for preschoolers' healthy dietary intakes, which suggested that future interventions and educational programs could enhance parenting practices to impact child diet.

Preoperative Breast MRI for Newly Diagnosed Ductal Carcinoma in Situ: Imaging Features and Performance in a Multicenter Setting (ECOG-ACRIN E4112 Trial).

Background There are limited data from clinical trials describing preoperative MRI features and performance in the evaluation of mammographically detected ductal carcinoma in situ (DCIS). Purpose To report qualitative MRI features of DCIS, MRI performance in the identification of additional disease, and associations of imaging features with pathologic, genomic, and surgical outcomes from the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) E4112 trial. Materials and Methods Secondary analyses of a multicenter prospective clinical trial from the ECOG-ACRIN Cancer Research Group included women with DCIS diagnosed with conventional imaging techniques (mammography and US), confirmed via core-needle biopsy (CNB), and enrolled between March 2015 and April 2016 who were candidates for wide local excision (WLE) based on conventional imaging and clinical examination results. DCIS MRI features and pathologic features from CNB and excision were recorded. Each woman without invasive upgrade of the index DCIS at WLE received a 12-gene DCIS score. MRI performance metrics were calculated. Associations of imaging features with invasive upgrade, dichotomized DCIS score (<39 vs ≥39), and single WLE success were estimated in uni- and multivariable analyses. Results Among 339 women (median age, 60 years; interquartile range, 51-66 years), most DCIS cases showed nonmass enhancement (NME) (195 of 339 [58%]) on MRI scans with larger median size than on mammograms (19 mm vs 12 mm; P < .001). Positive predictive value of MRI-prompted CNBs was 32% (21 of 66) (95% CI: 22, 44), yielding an additional cancer detection rate of 6.2% (21 of 339) (95% CI: 4.1, 9.3). MRI false-positive rate was 14.2% (45 of 318) (95% CI: 10.7, 18.4). No imaging features were associated with invasive upgrade or DCIS score (P = .05 to P = .95). Smaller size and focal NME distribution at MRI were linked to single WLE success (P < .001). Conclusion Preoperative MRI depicted ductal carcinoma in situ (DCIS) diagnosed with conventional imaging most commonly as nonmass enhancement, with larger median span than mammography, and additional cancer detection rate of 6.2%. MRI features of this subset of DCIS did not enable prediction of pathologic or genomic outcomes. Clinical trial registration no. NCT02352883 © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Kuhl in this issue. An earlier incorrect version of this article appeared online. This article was corrected on August 4, 2021.

Factors Affecting Image Quality and Lesion Evaluability in Breast Diffusion-weighted MRI: Observations from the ECOG-ACRIN Cancer Research Group Multisite Trial (A6702).

OBJECTIVE: The A6702 multisite trial confirmed that apparent diffusion coefficient (ADC) measures can improve breast MRI accuracy and reduce unnecessary biopsies, but also found that technical issues rendered many lesions non-evaluable on diffusion-weighted imaging (DWI). This secondary analysis investigated factors affecting lesion evaluability and impact on diagnostic performance. METHODS: The A6702 protocol was IRB-approved at 10 institutions; participants provided informed consent. In total, 103 women with 142 MRI-detected breast lesions (BI-RADS assessment category 3, 4, or 5) completed the study. DWI was acquired at 1.5T and 3T using a four b-value, echo-planar imaging sequence. Scans were reviewed for multiple quality factors (artifacts, signal-to-noise, misregistration, and fat suppression); lesions were considered non-evaluable if there was low confidence in ADC measurement. Associations of lesion evaluability with imaging and lesion characteristics were determined. Areas under the receiver operating characteristic curves (AUCs) were compared using bootstrapping. RESULTS: Thirty percent (42/142) of lesions were non-evaluable on DWI; 23% (32/142) with image quality issues, 7% (10/142) with conspicuity and/or localization issues. Misregistration was the only factor associated with non-evaluability (P = 0.001). Smaller (≤10 mm) lesions were more commonly non-evaluable than larger lesions (p <0.03), though not significant after multiplicity correction. The AUC for differentiating benign and malignant lesions increased after excluding non-evaluable lesions, from 0.61 (95% CI: 0.50-0.71) to 0.75 (95% CI: 0.65-0.84). CONCLUSION: Image quality remains a technical challenge in breast DWI, particularly for smaller lesions. Protocol optimization and advanced acquisition and post-processing techniques would help to improve clinical utility.

Utility of Targeted Ultrasound to Predict Malignancy Among Lesions Detected on Contrast-Enhanced Digital Mammography.

BACKGROUND. Targeted ultrasound (US) can be performed to characterize and potentially biopsy areas of enhancement detected on contrast-enhanced mammography (CEM). OBJECTIVE. The purpose of this study was to assess the utility of targeted US in predicting malignancy of lesions with indeterminate or suspicious enhancement on CEM. METHODS. One thousand consecutive CEM examinations with same-day targeted breast US at one institution between October 2013 and May 2018 were retrospectively reviewed. All patients with indeterminate or suspicious enhancement detected on CEM that underwent US evaluation were included. Patients with palpable or symptomatic lesions, those with suspicious findings on low-energy mammograms or images obtained with another modality, and those with less than 1 year of follow-up were excluded. Medical records, imaging, and pathology data were reviewed. Histopathologic analysis was used as the reference standard for biopsied lesions, and follow-up imaging was used for unbiopsied lesions. Associations between pathologic diagnosis, presence of a US correlate, and lesion characteristics were assessed by Fisher exact, chi-square, and Wilcox-on rank sum tests. RESULTS. Among 153 enhancing lesions detected on CEM in 144 patients, 47 (31%) had a US correlate. The frequency of a correlate between CEM and US was significantly higher among enhancing masses (28/43 [65%]) than among lesions exhibiting nonmass enhancement (19/110 [17%]) (p < .001). The likelihood of malignancy was significantly greater among lesions with a US correlate (12/47 [26%]) than among those without a US correlate (11/106 [10%]) (p = .03), and among mass lesions (11/43 [26%]) than among nonmass lesions (12/110 [11%]) (p = .04). The PPV of US-guided biopsy after CEM-directed US was 32%. CONCLUSION. Enhancing CEM-detected lesions that have a US correlate are more likely to be malignant and can be evaluated with US-guided biopsy to obviate additional breast MRI. CLINICAL IMPACT. CEM-directed US of enhancing lesions is useful given that lesions with a US correlate are more likely to be malignant and can be used as targets for US-guided biopsy until a CEM biopsy system becomes commercially available.

Mean Apparent Diffusion Coefficient Is a Sufficient Conventional Diffusion-weighted MRI Metric to Improve Breast MRI Diagnostic Performance: Results from the ECOG-ACRIN Cancer Research Group A6702 Diffusion Imaging Trial.

Background The Eastern Cooperative Oncology Group and American College of Radiology Imaging Network Cancer Research Group A6702 multicenter trial helped confirm the potential of diffusion-weighted MRI for improving differential diagnosis of suspicious breast abnormalities and reducing unnecessary biopsies. A prespecified secondary objective was to explore the relative value of different approaches for quantitative assessment of lesions at diffusion-weighted MRI. Purpose To determine whether alternate calculations of apparent diffusion coefficient (ADC) can help further improve diagnostic performance versus mean ADC values alone for analysis of suspicious breast lesions at MRI. Materials and Methods This prospective trial (ClinicalTrials.gov identifier: NCT02022579) enrolled consecutive women (from March 2014 to April 2015) with a Breast Imaging Reporting and Data System category of 3, 4, or 5 at breast MRI. All study participants underwent standardized diffusion-weighted MRI (b = 0, 100, 600, and 800 sec/mm2). Centralized ADC measures were performed, including manually drawn whole-lesion and hotspot regions of interest, histogram metrics, normalized ADC, and variable b-value combinations. Diagnostic performance was estimated by using the area under the receiver operating characteristic curve (AUC). Reduction in biopsy rate (maintaining 100% sensitivity) was estimated according to thresholds for each ADC metric. Results Among 107 enrolled women, 81 lesions with outcomes (28 malignant and 53 benign) in 67 women (median age, 49 years; interquartile range, 41-60 years) were analyzed. Among ADC metrics tested, none improved diagnostic performance versus standard mean ADC (AUC, 0.59-0.79 vs AUC, 0.75; P = .02-.84), and maximum ADC had worse performance (AUC, 0.52; P < .001). The 25th-percentile ADC metric provided the best performance (AUC, 0.79; 95% CI: 0.70, 0.88), and a threshold using median ADC provided the greatest reduction in biopsy rate of 23.9% (95% CI: 14.8, 32.9; 16 of 67 BI-RADS category 4 and 5 lesions). Nonzero minimum b value (100, 600, and 800 sec/mm2) did not improve the AUC (0.74; P = .28), and several combinations of two b values (0 and 600, 100 and 600, 0 and 800, and 100 and 800 sec/mm2; AUC, 0.73-0.76) provided results similar to those seen with calculations of four b values (AUC, 0.75; P = .17-.87). Conclusion Mean apparent diffusion coefficient calculated with a two-b-value acquisition is a simple and sufficient diffusion-weighted MRI metric to augment diagnostic performance of breast MRI compared with more complex approaches to apparent diffusion coefficient measurement. © RSNA, 2020 Online supplemental material is available for this article.

Outcome of Screening MRI in Premenopausal Women as a Function of the Week of the Menstrual Cycle.

OBJECTIVE. The objective of our study was to determine whether there are differences in outcome of screening MRI examinations in premenopausal women as a function of the week of the menstrual cycle in which the study was performed. MATERIALS AND METHODS. The reports of consecutive screening MRI examinations performed from January 1, 2011, through December 31, 2012, of premenopausal women were reviewed. Only cases for which the 1st day of the last menstrual cycle was documented were included. Associations between the week of the menstrual cycle, degree of background parenchymal enhancement (BPE), final BI-RADS assessment, positive predictive values (PPVs), cancer detection rate (CDR), sensitivity, and specificity were noted. RESULTS. A total of 1536 MRI examinations of 1239 women were performed. Distribution of MRI examinations by menstrual cycle week was as follows: 21.8% (n = 335) in week 1, 35.4% (n = 544) in week 2, 23.4% (n = 360) in week 3, and 19.3% (n = 297) in week 4. In the overall comparison, there was no significant difference in BPE, BI-RADS assessment, PPV1, PPV2, PPV3, CDR, sensitivity, or specificity by the week of the menstrual cycle. When outcomes for cases with MRI performed in week 2 were compared with those of cases with MRI performed in weeks 1, 3, and 4 combined, there was no significant difference in the same outcome measures. CONCLUSION. There was no evidence of a difference in outcomes of screening MRI examinations as a function of the week of menstrual cycle in which the study is performed. The results of our study do not support the need for screening MRI to be performed in week 2 of the menstrual cycle.

Survival Outcomes of Screening with Breast MRI in Women at Elevated Risk of Breast Cancer.

OBJECTIVE: To determine survival outcomes in women with breast cancer detected at combined screening with breast MRI and mammography versus screening mammography alone. METHODS: This is an institutional review board-approved retrospective study, and the need for informed consent was waived. A total of 3002 women with an increased risk of breast cancer were screened between 2001 and 2004. Of the 3002 women, 1534 (51.1%) had 2780 combined screenings (MRI and mammography) and 1468 (48.9%) had 4811 mammography-only screenings. The Χ 2 test and the Kaplan-Meier method were used to compare cancer detection rates and survival rates. RESULTS: The overall cancer detection rate was significantly higher in the MRI plus mammography group compared with the mammography-only group (1.4% [40 of 2780] vs 0.5% [23 of 4811]; P < 0.001). No interval cancers occurred in the MRI plus mammography group, whereas 9 interval cancers were found in the mammography-only group. During a median follow-up of 10.9 years (range: 0.7 to 15.2), a total of 11 recurrences and 5 deaths occurred. Of the 11 recurrences, 6 were in the MRI plus mammography group and 5 were in the mammography-only group. All five deaths occurred in the mammography-only group. Disease-free survival showed no statistically significant difference between the two groups (P = 0.32). However, overall survival was significantly improved in the MRI plus mammography group (P = 0.002). CONCLUSION: Combined screening with MRI and mammography in women at elevated risk of breast cancer improves cancer detection and overall survival.

Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening.

Importance: Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography. Objective: To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts. Design, Setting, and Participants: Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019. Exposures: All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias. Main Outcomes and Measures: The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity. Results: Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15). Conclusions and Relevance: Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT02933489.

Breast mass segmentation in ultrasound with selective kernel U-Net convolutional neural network.

In this work, we propose a deep learning method for breast mass segmentation in ultrasound (US). Variations in breast mass size and image characteristics make the automatic segmentation difficult. To address this issue, we developed a selective kernel (SK) U-Net convolutional neural network. The aim of the SKs was to adjust network's receptive fields via an attention mechanism, and fuse feature maps extracted with dilated and conventional convolutions. The proposed method was developed and evaluated using US images collected from 882 breast masses. Moreover, we used three datasets of US images collected at different medical centers for testing (893 US images). On our test set of 150 US images, the SK-U-Net achieved mean Dice score of 0.826, and outperformed regular U-Net, Dice score of 0.778. When evaluated on three separate datasets, the proposed method yielded mean Dice scores ranging from 0.646 to 0.780. Additional fine-tuning of our better-performing model with data collected at different centers improved mean Dice scores by ~6%. SK-U-Net utilized both dilated and regular convolutions to process US images. We found strong correlation, Spearman's rank coefficient of 0.7, between the utilization of dilated convolutions and breast mass size in the case of network's expansion path. Our study shows the usefulness of deep learning methods for breast mass segmentation. SK-U-Net implementation and pre-trained weights can be found at github.com/mbyr/bus_seg.

Performance of Dual-Energy Contrast-enhanced Digital Mammography for Screening Women at Increased Risk of Breast Cancer.

BackgroundContrast agent-enhanced digital mammography (CEDM) has been shown to be more sensitive and specific than two-dimensional full-field digital mammography in the diagnostic setting. Few studies have reported on its performance in the screening setting.PurposeTo evaluate the performance of CEDM for breast cancer screening.Materials and MethodsThis retrospective study included women who underwent dual-energy CEDM for breast cancer screening from December 2012 through April 2016. Medical records were reviewed for age, risk factors, short-interval follow-up and biopsies recommended, and cancers detected. Sensitivity, specificity, positive predictive value of abnormal findings at screening (PPV1), positive predictive value of biopsy performed (PPV3), and negative predictive value were determined.ResultsIn the study period 904 baseline CEDMs were performed. Mean age was 51.8 years ± 9.4 (standard deviation). Of 904 patients, 700 (77.4%) had dense breasts, 247 (27.3%) had a family history of breast cancer in a first-degree relative age 50 years or younger, and 363 (40.2%) a personal history of breast cancer. The final Breast Imaging Reporting and Data System score was 1 or 2 in 832 of 904 (92.0%) patients, score of 3 in 25 of 904 (2.8%) patients, and score of 4 or 5 in 47 of 904 (5.2%) patients. By using CEDM, 15 cancers were diagnosed in 14 of 904 women (cancer detection rate, 15.5 of 1000). PPV3 was 29.4% (15 of 51). At least 1-year follow up was available in 858 women. There were two interval cancers. Sensitivity was 50.0% (eight of 16; 95% confidence interval [CI]: 24.7%, 75.3%) on the low-energy images compared with 87.5% (14 of 16; 95% CI: 61.7%, 98.4%) for the entire study (low-energy and iodine images; P = .03). Specificity was 93.7% (789 of 842; 95% CI: 91.8%, 95.2%); PPV1 was 20.9% (14 of 67; 95% CI: 11.9%, 32.6%), and negative predictive value was 99.7% (789 of 791; 95% CI: 99.09%, 99.97%).ConclusionContrast-enhanced digital mammography is a promising technique for screening women with higher-than-average risk for breast cancer.© RSNA, 2019.