Clinical trial · Interventional
Mammography Screening With Artificial Intelligence (MASAI)
A Randomized, Single-blinded, Controlled Trial on the Efficacy of Mammography Screening With Artificial Intelligence - the MASAI Study
NCT04838756CI-TRIAL-00107113MASAIcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this randomized controlled trial is to assess whether AI can improve the efficacy of mammography screening, by adapting single and double reading based on AI derived cancer-risk scores and to use AI as a decision support in the screen reading, compared with conventional mammography screening (double reading without AI).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI screening modality | Other | — | UNRESOLVED |
| Conventional screening modality | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- AI-integrated mammography screening
- interventionNames
- Other: AI screening modality
- type
- EXPERIMENTAL
- label
- Control arm
- description
- Conventional mammography screening (standard of care)
- interventionNames
- Other: Conventional screening modality
Primary outcomes (1)
- measure
- Interval-cancer rate
- timeFrame
- 43 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: Women eligible for population-based mammography screening. Exclusion Criteria: None.
References
Publications (3)
- RESULTLang K, Josefsson V, Larsson AM, Larsson S, Hogberg C, Sartor H, Hofvind S, Andersson I, Rosso A. 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. Lancet Oncol. 2023 Aug;24(8):936-944. doi: 10.1016/S1470-2045(23)00298-X. PMID 37541274
- RESULTHernstrom V, Josefsson V, Sartor H, Schmidt D, Larsson AM, Hofvind S, Andersson I, Rosso A, Hagberg O, Lang K. 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. Lancet Digit Health. 2025 Mar;7(3):e175-e183. doi: 10.1016/S2589-7500(24)00267-X. Epub 2025 Feb 3. PMID 39904652
- DERIVEDGommers J, Hernstrom V, Josefsson V, Sartor H, Schmidt D, Hjelmgren A, Larsson AM, Hofvind S, Andersson I, Rosso A, Hagberg O, Lang K. 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. Lancet. 2026 Jan 31;407(10527):505-514. doi: 10.1016/S0140-6736(25)02464-X. PMID 41620232