Multi-site validation of an image-based AI breast cancer risk model for mammography to drive personalized screening after a negative screening
Author Block: A. D. Lauritzen1, A. Rodriguez-Ruiz2, N. Karssemeijer2, C. De Wolf3, R. Mann2, M. Nielsen1, I. Vejborg4, M. Lillholm1; 1Copenhagen/DK, 2Nijmegen/NL, 3Geneva/CH, 4Gentofte/DK
Purpose: To validate the performance of an image-based AI breast cancer risk model to stratify women attending screening after a negative screening.
Methods or Background: Exams from women attending two European screening programs (Denmark and Switzerland) and from a public U.S. database (EMBED) were consecutively sampled. All exams were screen-negative (cancer-free for 180 days) and had follow-up information of between two and six years. Mammography exams were processed by an AI breast cancer risk model (Transpara Risk, ScreenPoint Medical, trial version for research). The risk model computes three image biomarkers (suspicious findings, volumetric breast density, breast texture), and combined with age, it generates a five-year breast cancer risk score per exam. All exams were fully independent from the development of the risk model. Risk model AUCs were computed for each cohort along with sensitivity for women with the highest 10% risk and breast density, respectively.
Results or Findings: In total, 98,084 exams were included (31,349, 17,445, and 49,290 from Switzerland, US, and Denmark, respectively) with 1,336 breast cancers diagnosed within 5 years from screening. Images were acquired with machines from four manufacturers (Hologic, Siemens, GE, Philips). The AUCs of the AI risk model were 0.73 (95% CI: 0.69-0.76), 0.74 (95% CI: 0.69-0.79) and 0.74 (95% CI: 0.73-0.76) for Switzerland, US, and Denmark, respectively. When simulating using risk to offer supplemental imaging to 10% of women, after a negative screening, sensitivity was 37% (95% CI: 34%-39%), in comparison to 15% (95% CI: 13-17%) when using density alone.
Conclusion: An image-based AI breast cancer risk model shows high accuracy and robustness to stratify women attending screening according to risk and could support personalized screening with higher sensitivity than breast density.
Limitations: The retrospective study design is a limitation of this study.
Funding for this study: Supported in part by Eurostars (grant E9714 IBSCREEN)
Has your study been approved by an ethics committee? Not applicable
Ethics committee - additional information: The Danish Patient Safety Authority and Danish Data Protection Agency approved this retrospective study and the use of relevant Danish data, and waived the need for informed consent (ref. 3–3013–2118, addendum 2019/2023).