PURPOSE

We developed an artificial intelligence system (AIS) using multi-view multi-level convolutional neural networks for breast cancer detection, diagnosis, and BI-RADS categorization support in mammography.

METHODS

Twenty-four thousand eight hundred sixty-six breasts from 12,433 Asian women between August 2012 and December 2018 were enrolled. The study consisted of three parts: (1) evaluation of AIS performance in malignancy diagnosis; (2) stratified analysis of BI-RADS 3-4 subgroups with AIS; and (3) reassessment of BI-RADS 0 breasts with AIS assistance. We further evaluate AIS by conducting a counterbalance-designed AI-assisted study, where ten radiologists read 1302 cases with/without AIS assistance. The area under the receiver operating characteristic curve (AUC), sensitivity, specificity, accuracy, and F1 score were measured.

RESULTS

The AIS yielded AUC values of 0.995, 0.933, and 0.947 for malignancy diagnosis in the validation set, testing set 1, and testing set 2, respectively. Within BI-RADS 3-4 subgroups with pathological results, AIS downgraded 83.1% of false-positives into benign groups, and upgraded 54.1% of false-negatives into malignant groups. AIS also successfully assisted radiologists in identifying 7 out of 43 malignancies initially diagnosed with BI-RADS 0, with a specificity of 96.7%. In the counterbalance-designed AI-assisted study, the average AUC across ten readers significantly improved with AIS assistance (p = 0.001).

CONCLUSION

AIS can accurately detect and diagnose breast cancer on mammography and further serve as a supportive tool for BI-RADS categorization.

CRITICAL RELEVANCE STATEMENT

An AI risk assessment tool employing deep learning algorithms was developed and validated for enhancing breast cancer diagnosis from mammograms, to improve risk stratification accuracy, particularly in patients with dense breasts, and serve as a decision support aid for radiologists.

KEY POINTS

The false positive and negative rates of mammography diagnosis remain high. The AIS can yield a high AUC for malignancy diagnosis. The AIS is important in stratifying BI-RADS categorization.