{"id":"AIBD-0642","title":"MASAI randomized trial in southwest Sweden: Transpara-supported mammography screening finds more cancers with less screen reading and a non-inferior interval cancer rate","summary":"In the MASAI trial of 105,934 women, Transpara-supported screening found 6.4 cancers per 1,000 against 5.0 with standard double reading and cut screen reading by 44.2%.","date_observed":"2022-12-07","date_basis":"event","date_precision":"day","benefit_status":"reported","source_collection":null,"source_entry":null,"account":"Researchers at Lund University ran the MASAI trial inside the Swedish national screening program at four screening sites in southwest Sweden: Malmö, Lund, Landskrona and Trelleborg. Between 12 April 2021 and 7 December 2022 they randomly assigned 105,934 women to AI-supported screening or to standard double reading by two radiologists without AI. In the AI group, Transpara version 1.7.0 from ScreenPoint Medical gave each examination a risk score from 1 to 10. Examinations scored 10 went to two readers and all others went to one reader. The readers saw the risk score of every examination and, for examinations scored 8 to 10, the marks that the system placed on suspicious areas. The AI group had 338 screen-detected cancers among 53,043 women and the control group had 262 among 52,872, a detection rate of 6.4 per 1,000 against 5.0 per 1,000. The extra invasive cancers were mainly small and node-negative. Recall and false-positive rates did not rise significantly, and screen readings fell by 44.2%. The primary outcome, published in The Lancet in 2026, was the interval cancer rate: 1.55 per 1,000 with AI and 1.76 per 1,000 without, which met the trial's non-inferiority margin. Sensitivity was 80.5% with AI and 73.8% without. The difference in interval cancers was not statistically significant, and the trial tested one AI product in one region.","category":"general benefit","unexpected":false,"purpose":"Transpara was built to detect breast cancer on screening mammograms and to score examinations by risk. In MASAI it triaged examinations to single or double reading and marked suspicious findings; the higher detection and the saved reading time were that purpose.","system":"Transpara","model_version":"1.7.0","developer":"ScreenPoint Medical","deployer":"Unilabs Mammography Unit at Skåne University Hospital with Lund University (MASAI trial, Swedish national screening program)","location":"Malmö, Lund, Landskrona and Trelleborg, Skåne, Sweden","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"personal","depth":4,"reason":"Women in the AI group had 338 cancers found at screening against 262 in the control group, and the extra invasive cancers were mainly small and node-negative."},{"group":"organizational","depth":2,"reason":"The screening service needed 61,248 screen readings in the AI group against 109,692 in the control group, a 44.2% reduction."}],"ai_role":{"status":"assessed","statement":"The trial randomly assigned women to AI-supported screening or to standard double reading without AI, so the difference in outcomes reflects the AI-supported workflow. The design does not separate the effect of triage from the effect of the detection marks."},"evidence":[{"kind":"peer-reviewed study","citation":"Gommers J, Hernström V, Josefsson V, et al. Interval cancer, sensitivity, and specificity comparing AI-supported mammography screening with standard double reading without AI in the MASAI study. Lancet. 2026. doi:10.1016/S0140-6736(25)02464-X","title":"Interval cancer, sensitivity, and specificity comparing AI-supported mammography screening with standard double reading without AI in the MASAI study: a randomised, controlled, non-inferiority, single-blinded, population-based, screening-accuracy trial","url":"https://pubmed.ncbi.nlm.nih.gov/41620232/","date":"2026-01-01","written_by":"independent","quote":"Interval cancer rates were 1·55 (95% CI 1·23-1·92) and 1·76 (1·42-2·15) per 1000 participants in the intervention and control group respectively, a non-inferior proportion ratio of 0·88 (95% CI 0·65-1·18; p=0·41)."},{"kind":"peer-reviewed study","citation":"Hernström V, Josefsson V, Sartor H, et al. Screening performance and characteristics of breast cancer detected in the Mammography Screening with Artificial Intelligence trial (MASAI). Lancet Digit Health. 2025. doi:10.1016/S2589-7500(24)00267-X","title":"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","url":"https://pubmed.ncbi.nlm.nih.gov/39904652/","date":"2025-02-03","written_by":"independent","quote":"Cancer-detection rates were 6·4 per 1000 (95% CI 5·7-7·1) screened participants in the intervention group and 5·0 per 1000 (4·4-5·6) in the control group, a ratio of 1·29 (95% CI 1·09-1·51; p=0·0021)."},{"kind":"peer-reviewed study","citation":"Lång K, Josefsson V, Larsson AM, et al. Artificial intelligence-supported screen reading versus standard double reading in the Mammography Screening with Artificial Intelligence trial (MASAI). Lancet Oncol. 2023. doi:10.1016/S1470-2045(23)00298-X","title":"Artificial intelligence-supported screen reading versus standard double reading in the Mammography Screening with Artificial Intelligence trial (MASAI): a clinical safety analysis of a randomised, controlled, non-inferiority, single-blinded, screening accuracy study","url":"https://pubmed.ncbi.nlm.nih.gov/37541274/","date":"2023-08-01","written_by":"independent","quote":"The AI system (Transpara version 1.7.0) provided an examination-based malignancy risk score on a 10-level scale that was used to triage screening examinations to single reading (score 1-9) or double reading (score 10)"},{"kind":"peer-reviewed study","citation":"Ferre R, Benefield T, Kuzmiak CM. Artificial intelligence-supported double reading in European population breast cancer screening: a systematic review and meta-analysis of prospective programs. Clin Imaging. 2026;139:110923. doi:10.1016/j.clinimag.2026.110923","title":"Artificial intelligence-supported double reading in European population breast cancer screening: A systematic review and meta-analysis of prospective programs","url":"https://pubmed.ncbi.nlm.nih.gov/42617468/","date":"2026-08-11","written_by":"independent","quote":"Efficiency signals included 44.3% fewer total readings in MASAI"},{"kind":"peer-reviewed study","citation":"Ciurescu S, Buciu V, Ilaș DG, Pârvănescu R, Șerban D. Ten years of artificial intelligence in screening mammography: a systematic review and meta-analysis of diagnostic accuracy and clinical implementation (literature published 2015-2025). Diagnostics (Basel). 2026;16(18):3045. doi:10.3390/diagnostics16183045","title":"Ten Years of Artificial Intelligence in Screening Mammography: A Systematic Review and Meta-Analysis of Diagnostic Accuracy and Clinical Implementation (Literature Published 2015-2025)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13605948/","date":"2026-09-20","written_by":"independent","quote":"Across randomised and paired prospective trials (k = 3), the pooled detection rate ratio was 1.13 (0.83-1.55), with the MASAI randomised trial alone reporting 1.29 (1.09-1.51) and a 44% reduction in screen reading."}],"replication":{"produced_by":["Transpara 1.7.0 scored every screening examination on a scale from 1 to 10.","Examinations scored 10 went to double reading and all others to single reading.","Readers saw the AI risk scores and detection marks while reading.","The trial ran inside an organized population screening program with experienced breast radiologists."],"must_hold":["Readers must have the AI scores and marks in front of them when they read.","The AI must perform on the local equipment and population as it did in the trial.","The program must use double reading that the AI triage can replace for low-risk examinations."],"echoes":[{"date":"2022-06-09","setting":"ScreenTrustCAD, Capio Sankt Göran Hospital, Stockholm, Sweden (Lunit Insight MMG)","model_version":null,"outcome":"recurred","source":"https://pubmed.ncbi.nlm.nih.gov/37690911/"},{"date":"2023-02-01","setting":"PRAIM, 12 sites of the German mammography screening program (Vara MG)","model_version":null,"outcome":"recurred","source":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11922743/"},{"date":"2024-01-01","setting":"Paired trial at Reina Sofía University Hospital, Córdoba, Spain (Transpara 1.7)","model_version":null,"outcome":"recurred","source":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13099413/"}]},"paired_incident":null,"headline":"*Transpara* helps Swedish breast screening find more cancers","metric":"a detection rate of 6.4 per 1,000 against 5.0 per 1,000","comparator":{"against":"Standard double reading by two radiologists without AI","before":"5.0 screen-detected cancers per 1,000 women","after":"6.4 screen-detected cancers per 1,000 women","basis":"measured","quote":"Cancer-detection rates were 6·4 per 1000 (95% CI 5·7-7·1) screened participants in the intervention group and 5·0 per 1000 (4·4-5·6) in the control group","url":"https://pubmed.ncbi.nlm.nih.gov/39904652/"},"later":null,"value":null,"developer_country":"Netherlands","deployer_country":"Sweden","unrated_because":null,"brief_notes":null,"brief":null,"revisions":[{"date":"2026-10-29","change":"Added the case.","source":"https://pubmed.ncbi.nlm.nih.gov/41620232/","editor":"AIBD"}],"confidence":"studied","shade":"high","claim_status":"Independently studied","claim_basis":"Sources: five independent peer-reviewed studies. 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Study 2: Standard double reading without AI.","inferred":false}},"evaluations[].design":{"state":"value_present","value":{"kind":"text","text":"Study 1: randomized. Study 2: randomized."},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":["AIBD-0642-source-0001","AIBD-0642-source-0002"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"Study 1: randomized. Study 2: randomized.","inferred":false}},"evaluations[].effect":{"state":"value_present","value":{"kind":"text","text":"Study 1: 1.55 vs 1.76 per 1,000; proportion ratio 0.88 (95% CI 0.65 to 1.18), non-inferior; sensitivity 80.5% vs 73.8%. Study 2: 6.4 vs 5.0 per 1,000 (ratio 1.29); 44.2% fewer screen readings."},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":["AIBD-0642-source-0001","AIBD-0642-source-0002"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"Study 1: 1.55 vs 1.76 per 1,000; proportion ratio 0.88 (95% CI 0.65 to 1.18), non-inferior; sensitivity 80.5% vs 73.8%. Study 2: 6.4 vs 5.0 per 1,000 (ratio 1.29); 44.2% fewer screen readings.","inferred":false}},"evaluations[].exposure":{"state":"value_present","value":{"kind":"text","text":"Study 1: AI triage plus detection support for all examinations in the intervention group. 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Study 2: Cancer detection rate per 1,000 and screen-reading workload."},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":["AIBD-0642-source-0001","AIBD-0642-source-0002"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"Study 1: Interval cancer rate per 1,000 participants. Study 2: Cancer detection rate per 1,000 and screen-reading workload.","inferred":false}},"evaluations[].reproduction_materials":{"state":"value_present","value":{"kind":"text","text":"Study 1: Trial registered as NCT04838756. Study 2: Trial registered as NCT04838756."},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":["AIBD-0642-source-0001","AIBD-0642-source-0002"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"Study 1: Trial registered as NCT04838756. 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Between 12 April 2021 and 7 December 2022 they randomly assigned 105,934 women to AI-supported screening or to standard double reading by two radiologists without AI. In the AI group, Transpara version 1.7.0 from ScreenPoint Medical gave each examination a risk score from 1 to 10. Examinations scored 10 went to two readers and all others went to one reader. The readers saw the risk score of every examination and, for examinations scored 8 to 10, the marks that the system placed on suspicious areas. The AI group had 338 screen-detected cancers among 53,043 women and the control group had 262 among 52,872, a detection rate of 6.4 per 1,000 against 5.0 per 1,000. The extra invasive cancers were mainly small and node-negative. Recall and false-positive rates did not rise significantly, and screen readings fell by 44.2%. The primary outcome, published in The Lancet in 2026, was the interval cancer rate: 1.55 per 1,000 with AI and 1.76 per 1,000 without, which met the trial's non-inferiority margin. Sensitivity was 80.5% with AI and 73.8% without. The difference in interval cancers was not statistically significant, and the trial tested one AI product in one region.","replication":{"produced_by":["Transpara 1.7.0 scored every screening examination on a scale from 1 to 10.","Examinations scored 10 went to double reading and all others to single reading.","Readers saw the AI risk scores and detection marks while reading.","The trial ran inside an organized population screening program with experienced breast radiologists."],"must_hold":["Readers must have the AI scores and marks in front of them when they read.","The AI must perform on the local equipment and population as it did in the trial.","The program must use double reading that the AI triage can replace for low-risk examinations."],"echoes":[{"date":"2022-06-09","setting":"ScreenTrustCAD, Capio Sankt Göran Hospital, Stockholm, Sweden (Lunit Insight MMG)","outcome":"recurred","source":"https://pubmed.ncbi.nlm.nih.gov/37690911/"},{"date":"2023-02-01","setting":"PRAIM, 12 sites of the German mammography screening program (Vara MG)","outcome":"recurred","source":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11922743/"},{"date":"2024-01-01","setting":"Paired trial at Reina Sofía University Hospital, Córdoba, Spain (Transpara 1.7)","outcome":"recurred","source":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13099413/"}]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":43,"reviewed":15,"reviewed_complete":14,"reviewed_partial":1,"record_mapped":29,"review_not_assessed":47,"not_assessed":0,"complete":false,"by_state":{"value_present":43,"not_reported":0,"unresolved":48,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"a064c19049c55690a92997044e107047c67de44fdd4d0a9323646e6a9fe05fba"}