Although deep learning models for abnormality classification can perform well in screening mammography, the demographic, imaging, and clinical characteristics associated with increased risk of model failure remain unclear. This retrospective study uses the Emory BrEast Imaging Dataset(EMBED) containing mammograms from 115931 patients imaged at Emory Healthcare between 2013-2020, with BI-RADS assessment, region of interest coordinates for abnormalities, imaging features, pathologic outcomes, and patient demographics. Multiple deep learning models were trained to distinguish between abnormal tissue patches and randomly selected normal tissue patches from screening mammograms. We assessed model performance by subgroups defined by age, race, pathologic outcome, tissue density, and imaging characteristics and investigated their associations with false negatives (FN) and false positives (FP). We also performed multivariate logistic regression to control for confounding between subgroups. The top-performing model, ResNet152V2, achieved accuracy of 92.6%(95%CI=92.0-93.2%), and AUC 0.975(95%CI=0.972-0.978). Before controlling for confounding, nearly all subgroups showed statistically significant differences in model performance. However, after controlling for confounding, we found lower FN risk associates with Other race(RR=0.828;p=.050), biopsy-proven benign lesions(RR=0.927;p=.011), and mass(RR=0.921;p=.010) or asymmetry(RR=0.854;p=.040); higher FN risk associates with architectural distortion (RR=1.037;p<.001). Higher FP risk associates to BI-RADS density C(RR=1.891;p<.001) and D(RR=2.486;p<.001). Our results demonstrate subgroup analysis is important in mammogram classifier performance evaluation, and controlling for confounding between subgroups elucidates the true associations between variables and model failure. These results can help guide developing future breast cancer detection models.

Breast cancer screening is one of the most common radiological tasks with over 39 million exams performed each year. While breast cancer screening has been one of the most studied medical imaging applications of artificial intelligence, the development and evaluation of the algorithms are hindered due to the lack of well-annotated large-scale publicly available datasets. This is particularly an issue for digital breast tomosynthesis (DBT) which is a relatively new breast cancer screening modality. We have curated and made publicly available a large-scale dataset of digital breast tomosynthesis images. It contains 22,032 reconstructed DBT volumes belonging to 5,610 studies from 5,060 patients. This included four groups: (1) 5,129 normal studies, (2) 280 studies where additional imaging was needed but no biopsy was performed, (3) 112 benign biopsied studies, and (4) 89 studies with cancer. Our dataset included masses and architectural distortions which were annotated by two experienced radiologists. Additionally, we developed a single-phase deep learning detection model and tested it using our dataset to serve as a baseline for future research. Our model reached a sensitivity of 65% at 2 false positives per breast. Our large, diverse, and highly-curated dataset will facilitate development and evaluation of AI algorithms for breast cancer screening through providing data for training as well as common set of cases for model validation. The performance of the model developed in our study shows that the task remains challenging and will serve as a baseline for future model development.

Question Can a curated, annotated, and publicly available data set of digital breast tomosynthesis (DBT) volumes be created for the development and validation of breast cancer computer-aided detection algorithms? Findings In this diagnostic study, a curated and annotated data set of DBT studies that contained 22 032 reconstructed DBT volumes from 5060 patients was made publicly available. A deep learning algorithm for breast cancer detection was developed and tested, with a sensitivity of 65% on a test set. Meaning In this study, the publicly available data set, alongside the deep learning model, could significantly advance the research on machine learning tools in breast cancer screening and medical imaging in general. Importance Breast cancer screening is among the most common radiological tasks, with more than 39 million examinations performed each year. While it has been among the most studied medical imaging applications of artificial intelligence, the development and evaluation of algorithms are hindered by the lack of well-annotated, large-scale publicly available data sets. Objectives To curate, annotate, and make publicly available a large-scale data set of digital breast tomosynthesis (DBT) images to facilitate the development and evaluation of artificial intelligence algorithms for breast cancer screening; to develop a baseline deep learning model for breast cancer detection; and to test this model using the data set to serve as a baseline for future research. Design, Setting, and Participants In this diagnostic study, 16 802 DBT examinations with at least 1 reconstruction view available, performed between August 26, 2014, and January 29, 2018, were obtained from Duke Health System and analyzed.

Early detection of breast cancer can increase treatment efficiency. Architectural Distortion (AD) is a very subtle contraction of the breast tissue and may represent the earliest sign of cancer. Since it is very likely to be unnoticed by radiologists, several approaches have been proposed over the years but none using deep learning techniques. To train a Convolutional Neural Network (CNN), which is a deep neural architecture, is necessary a huge amount of data. To overcome this problem, this paper proposes a data augmentation approach applied to clinical image dataset to properly train a CNN. Results using receiver operating characteristic analysis showed that with a very limited dataset we could train a CNN to detect AD in digital mammography with area under the curve (AUC = 0.74).