Objectives: Radiologists' visual assessment of breast mammographic density (BMD) is subject to inter-observer variability. We aimed to develop and validate a new automated software tool mimicking expert radiologists' consensus assessments of 2D BMD, as per BI-RADS V recommendations.
Methods: The software algorithm was developed using a concept of Manhattan distance to compare a patient's mammographic image to reference mammograms with an assigned BMD category. Reference databases were built from a total of 2289 pairs (cranio-caudal and medio-lateral oblique views) of 2D full-field digital mammography (FFDM). Each image was independently assessed for BMD by a consensus of radiologists specialized in breast imaging. A validation set of additional 800 image pairs was evaluated for BMD both by the software and seven blinded radiologists specialized in breast imaging. The median score was used for consensus. Software reproducibility was assessed using FFDM image pairs from 214 patients in the validation set to compare BMD assessment between left and right breasts.
Results: The software showed a substantial agreement with the radiologists' consensus (unweighted κ = 0.68, 95% CI 0.64-0.72) when considering the four breast density categories, and an almost perfect agreement (unweighted κ = 0.84, 95% CI 0.80-0.88) when considering clinically significant non-dense (A-B) and dense (C-D) categories. Correlation between left and right breasts was high (rs = 0.87; 95% CI 0.84-0.90).
Conclusions: BMD assessment by the software was strongly correlated to radiologists' consensus assessments of BMD. Its performance should be compared to other methods, and its clinical utility evaluated in a risk assessment model.
Key points: • A new software tool assesses breast density in a standardized way. • The tool mimics radiologists' clinical assessment of breast density. • It may be incorporated in a breast cancer risk assessment model.
Keywords: Breast cancer; Breast density; Mammography; Risk assessment; Software.