Artificial intelligence for breast cancer detection in screening mammography in Sweden: a prospective, population-based, paired-reader, non-inferiority study

BACKGROUND: Artificial intelligence (AI) as an independent reader of screening mammograms has shown promise, but there are few prospective studies. Our aim was to conduct a prospective clinical trial to examine how AI affects cancer detection and false positive findings in a real-world setting. METHODS: ScreenTrustCAD was a prospective, population-based, paired-reader, non-inferiority study done at the Capio Sankt Göran Hospital in Stockholm, Sweden. Consecutive women without breast implants aged 40-74 years participating in population-based screening in the geographical uptake area of the study hospital were included. The primary outcome was screen-detected breast cancer within 3 months of mammography, and the primary analysis was to assess non-inferiority (non-inferiority margin of 0·15 relative reduction in breast cancer diagnoses) of double reading by one radiologist plus AI compared with standard-of-care double reading by two radiologists. We also assessed single reading by AI alone and triple reading by two radiologists plus AI compared with standard-of-care double reading by two radiologists. This study is registered with ClinicalTrials.gov, NCT04778670. FINDINGS: From April 1, 2021, to June 9, 2022, 58 344 women aged 40-74 years underwent regular mammography screening, of whom 55 581 were included in the study. 269 (0·5%) women were diagnosed with screen-detected breast cancer based on an initial positive read: double reading by one radiologist plus AI was non-inferior for cancer detection compared with double reading by two radiologists (261 [0·5%] vs 250 [0·4%] detected cases; relative proportion 1·04 [95% CI 1·00-1·09]). Single reading by AI (246 [0·4%] vs 250 [0·4%] detected cases; relative proportion 0·98 [0·93-1·04]) and triple reading by two radiologists plus AI (269 [0·5%] vs 250 [0·4%] detected cases; relative proportion 1·08 [1·04-1·11]) were also non-inferior to double reading by two radiologists. INTERPRETATION: Replacing one radiologist with AI for independent reading of screening mammograms resulted in a 4% higher non-inferior cancer detection rate compared with radiologist double reading. Our study suggests that AI in the study setting has potential for controlled implementation, which would include risk management and real-world follow-up of performance. FUNDING: Swedish Research Council, Swedish Cancer Society, Region Stockholm, and Lunit.