Artificial Intelligence for Breast Cancer Screening in Mammography (AI-STREAM): A Prospective Multicenter Study Design in Korea Using AI-Based CADe/x

PURPOSE: Artificial intelligence (AI)-based computer-aided detection/diagnosis (CADe/x) has helped improve radiologists’ performance and provides results equivalent or superior to those of radiologists’ alone. This prospective multicenter cohort study aims to generate real-world evidence on the overall benefits and disadvantages of using AI-based CADe/x for breast cancer detection in a population-based breast cancer screening program comprising Korean women aged ≥ 40 years. The purpose of this report is to compare the diagnostic accuracy of radiologists with and without the use of AI-based CADe/x in mammography readings for breast cancer screening of Korean women with average breast cancer risk. METHODS: Approximately 32,714 participants will be enrolled between February 2021 and December 2022 at 5 study sites in Korea. A radiologist specializing in breast imaging will interpret the mammography readings with or without the use of AI-based CADe/x. If recall is required, further diagnostic workup will be conducted to confirm the cancer detected on screening. The findings will be recorded for all participants regardless of their screening status to identify study participants with breast cancer diagnosis within both 1 year and 2 years of screening. The national cancer registry database will be reviewed in 2026 and 2027, and the results of this study are expected to be published in 2027. In addition, the diagnostic accuracy of general radiologists and radiologists specializing in breast imaging from another hospital with or without the use of AI-based CADe/x will be compared considering mammography readings for breast cancer screening. DISCUSSION: The Artificial Intelligence for Breast Cancer Screening in Mammography (AI-STREAM) study is a prospective multicenter study that aims to compare the diagnostic accuracy of radiologists with and without the use of AI-based CADe/x in mammography readings for breast cancer screening of women with average breast cancer risk. AI-STREAM is currently in the patient enrollment phase. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05024591