Background Mammography is the current standard for breast cancer screening. This study aimed to develop an artificial intelligence (AI) algorithm for diagnosis of breast cancer in mammography, and explore whether it could benefit radiologists by improving accuracy of diagnosis. Methods In this retrospective study, an AI algorithm was developed and validated with 170 230 mammography examinations collected from five institutions in South Korea, the USA, and the UK, including 36 468 cancer positive confirmed by biopsy, 59 544 benign confirmed by biopsy (8827 mammograms) or follow-up imaging (50 717 mammograms), and 74 218 normal. For the multicentre, observer-blinded, reader study, 320 mammograms (160 cancer positive, 64 benign, 96 normal) were independently obtained from two institutions. 14 radiologists participated as readers and assessed each mammogram in terms of likelihood of malignancy (LOM), location of malignancy, and necessity to recall the patient, first without and then with assistance of the AI algorithm. The performance of AI and radiologists was evaluated in terms of LOM-based area under the receiver operating characteristic curve (AUROC) and recall-based sensitivity and specificity. Findings The AI standalone performance was AUROC 0•959 (95% CI 0•952-0•966) overall, and 0•970 (0•963-0•978) in the South Korea dataset, 0•953 (0•938-0•968) in the USA dataset, and 0•938 (0•918-0•958) in the UK dataset. In the reader study, the performance level of AI was 0•940 (0•915-0•965), significantly higher than that of the radiologists without AI assistance (0•810, 95% CI 0•770-0•850; p<0•0001). With the assistance of AI, radiologists' performance was improved to 0•881 (0•850-0•911; p<0•0001). AI was more sensitive to detect cancers with mass (53 [90%] vs 46 [78%] of 59 cancers detected; p=0•044) or distortion or asymmetry (18 [90%] vs ten [50%] of 20 cancers detected; p=0•023) than radiologists. AI was better in detection of T1 cancers (73 [91%] vs 59 [74%] of 80; p=0•0039) or node-negative cancers (104 [87%] vs 88 [74%] of 119; p=0•0025) than radiologists. Interpretation The AI algorithm developed with large-scale mammography data showed better diagnostic performance in breast cancer detection compared with radiologists. The significant improvement in radiologists' performance when aided by AI supports application of AI to mammograms as a diagnostic support tool.
We assessed the feasibility of a data-driven imaging biomarker based on weakly supervised learning (DIB; an imaging biomarker derived from large-scale medical image data with deep learning technology) in mammography (DIB-MG). A total of 29,107 digital mammograms from five institutions (4,339 cancer cases and 24,768 normal cases) were included. After matching patients’ age, breast density, and equipment, 1,238 and 1,238 cases were chosen as validation and test sets, respectively, and the remainder were used for training. The core algorithm of DIB-MG is a deep convolutional neural network; a deep learning algorithm specialized for images. Each sample (case) is an exam composed of 4-view images (RCC, RMLO, LCC, and LMLO). For each case in a training set, the cancer probability inferred from DIB-MG is compared with the per-case ground-truth label. Then the model parameters in DIB-MG are updated based on the error between the prediction and the ground-truth. At the operating point (threshold) of 0.5, sensitivity was 75.6% and 76.1% when specificity was 90.2% and 88.5%, and AUC was 0.903 and 0.906 for the validation and test sets, respectively. This research showed the potential of DIB-MG as a screening tool for breast cancer.
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