Deep-LIBRA: Artificial intelligence method for robust quantification of breast density with independent validation in breast cancer risk assessment

Breast density is an important risk factor for breast cancer that also affects the specificity and sensitivity of screening mammography. Current federal legislation mandates reporting of breast density for all women undergoing breast screening. Clinically, breast density is assessed visually using the American College of Radiology Breast Imaging Reporting And Data System (BI-RADS) scale. Here, we introduce an artificial intelligence (AI) method to estimate breast percentage density (PD) from digital mammograms. Our method leverages deep learning (DL) using two convolutional neural network architectures to accurately segment the breast area. A machine-learning algorithm combining superpixel generation, texture feature analysis, and support vector machine is then applied to differentiate dense from non-dense tissue regions, from which PD is estimated. Our method has been trained and validated on a multi-ethnic, multi-institutional dataset of 15,661 images (4,437 women), and then tested on an independent dataset of 6,368 digital mammograms (1,702 women; cases=414) for both PD estimation and discrimination of breast cancer. On the independent dataset, PD estimates from Deep-LIBRA and an expert reader were strongly correlated (Spearman correlation coefficient = 0.90). Moreover, Deep-LIBRA yielded a higher breast cancer discrimination performance (area under the ROC curve, AUC = 0.611 [95% confidence interval (CI): 0.583, 0.639]) compared to four other widely-used research and commercial PD assessment methods (AUCs = 0.528 to 0.588). Our results suggest a strong agreement of PD estimates between Deep-LIBRA and gold-standard assessment by an expert reader, as well as improved performance in breast cancer risk assessment over state-of-the-art open-source and commercial methods.