{"entity":{"id":"masai","kind":"trial","name":"MASAI (Mammography Screening with Artificial Intelligence)","aka":[],"tldr":"The first randomised trial of AI in breast screening found more cancers and cut radiologists' reading work almost in half without more false alarms.","summary":"The prespecified interim safety analysis (Lancet Oncology 2023) of 80,020 women reported a cancer detection rate of 6.1 per 1,000 in the AI-supported arm versus 5.1 per 1,000 with standard double reading, similar recall rates (2.2% versus 2.0%) and false-positive rates (1.5% in both), and a 44.3% reduction in screen-reading workload. The final analysis of the full cohort (published 2025) confirmed a 29% increase in cancer detection, driven by small invasive cancers and in situ disease, with the interval-cancer endpoint to follow. MASAI is the evidence base for the AI-as-one-reader model that several European programmes, and the NHS EDITH trial, are now adopting.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT04838756","url":"https://clinicaltrials.gov/study/NCT04838756"},{"label":"MASAI interim analysis (Lancet Oncol 2023)","url":"https://doi.org/10.1016/S1470-2045(23)00298-X"}],"tags":[],"related":[],"cancers":["breast-hr-positive","tnbc"],"sections":[],"technologies":["mammography","radiology-ai-screening"],"targets":[],"drugs":["transpara"],"companies":["screenpoint-medical"],"institutions":[],"pathways":[],"terms":["screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-masai-lancet-digit-health-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04838756","phase":"3","setting":"Population screening in Sweden: AI-supported reading (Transpara, single or double reading by risk score) versus standard double reading","sponsor":"Lund University / Region Skåne","result":"Cancer detection 6.1 vs 5.1 per 1,000; screen-reading workload reduced 44.3% (interim).","started":"2021-04-12","startedType":"actual","yearReported":2023,"enrolled":105934,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 100,000 participants (actual); the Lancet 2026 interval-cancer analysis reports 105,934 women randomly assigned between April 2021 and December 2022.","outcomes":[{"endpoint":"Cancer detection rate (interim analysis)","unit":"per 1,000 screened","arms":[{"name":"AI-supported screening","n":39996,"value":6.1},{"name":"Standard double reading","n":40024,"value":5.1}],"source":"https://doi.org/10.1016/S1470-2045(23)00298-X"}]},"route":"/trials/masai/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"radiology-ai-screening","kind":"technology","name":"AI in radiology","route":"/technologies/radiology-ai-screening/"},{"id":"mammography","kind":"technology","name":"Mammography & tomosynthesis","route":"/technologies/mammography/"}],"drug":[{"id":"transpara","kind":"drug","name":"Transpara","route":"/drugs/transpara/"}],"company":[{"id":"screenpoint-medical","kind":"company","name":"ScreenPoint Medical","route":"/companies/screenpoint-medical/"}],"term":[{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}],"paper":[{"id":"paper-masai-lancet-digit-health-2025","kind":"paper","name":"Screening performance and characteristics of breast cancer detected in the Mammography Screening with Artificial Intelligence trial (MASAI): a randomised, controlled, parallel-group, non-inferiority, single-blinded, screening accuracy study","route":"/key-papers/paper-masai-lancet-digit-health-2025/"}],"roadmap":[{"id":"ai-oncology-roadmap","kind":"roadmap","name":"AI in oncology roadmap: pattern readers → foundation models → agents in the workflow","route":"/roadmaps/ai-oncology-roadmap/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}]}}