Clinical trial · Observational
Artificial Intelligence for breaST canceR scrEening in mAMmography (AI-STREAM)
Artificial Intelligence for breaST canceR scrEening in mAMmography (AI-STREAM): A Prospective, Multicenter Cohort Study
NCT05024591CI-TRIAL-00070045unknownClinicalTrials.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)
This prospective study aims to generate real-world evidence on the overall benefits and disadvantages of using Lunit INSIGHT MMG AI based CADe/x for breast cancer detection in a population-based breast cancer screening program in Korea.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lunit INSIGHT MMG CADe/x for medical imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- same as study population
- description
- Use of AI-based CADe/x by breast radiologists
- interventionNames
- Device: Lunit INSIGHT MMG CADe/x for medical imaging
Primary outcomes (1)
- measure
- • Diagnostic accuracy with difference between breast radiologists with and without AI-based CADe/x
- timeFrame
- 12months after screening, 24months after screening
- description
- Diagnostic accuracy is assessed using cancer registry data as the reference group to calculate cancer detection rate \[CDR\], recall rate, sensitivity, positive predictive value
Secondary outcomes (1)
- measure
- • Diagnostic accuracy and difference of the following comparison groups with or without AI
- timeFrame
- 12months after screening, 24 months after screening
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must meet all of the following inclusion criteria in order to be enrolled in the study: * Be eligible for national cancer screening in the relevant year and visit the site for breast cancer screening * Provide consent for study participation using the Informed Consent Form and complete a Participant information Sheet Exclusion Criteria: * Participants who meet any of the following criteria will be excluded from the study: * Has a history of or current breast cancer * Is currently pregnant or plans to become pregnant in the next 12 months * Has a history of breast surgery (mammoplasty or insertion of a foreign substance, such as paraffin or silicon) * Has mammography for diagnostic purposes
References
Publications (5)
- BACKGROUNDKim HE, Kim HH, Han BK, Kim KH, Han K, Nam H, Lee EH, Kim EK. Changes in cancer detection and false-positive recall in mammography using artificial intelligence: a retrospective, multireader study. Lancet Digit Health. 2020 Mar;2(3):e138-e148. doi: 10.1016/S2589-7500(20)30003-0. Epub 2020 Feb 6. PMID 33334578
- BACKGROUNDSalim M, Wahlin E, Dembrower K, Azavedo E, Foukakis T, Liu Y, Smith K, Eklund M, Strand F. External Evaluation of 3 Commercial Artificial Intelligence Algorithms for Independent Assessment of Screening Mammograms. JAMA Oncol. 2020 Oct 1;6(10):1581-1588. doi: 10.1001/jamaoncol.2020.3321. PMID 32852536
- BACKGROUNDChang YW, An JK, Choi N, Ko KH, Kim KH, Han K, Ryu JK. Artificial Intelligence for Breast Cancer Screening in Mammography (AI-STREAM): A Prospective Multicenter Study Design in Korea Using AI-Based CADe/x. J Breast Cancer. 2022 Feb;25(1):57-68. doi: 10.4048/jbc.2022.25.e4. Epub 2022 Jan 6. PMID 35133093
- DERIVEDChang YW, Ryu JK, An JK, Choi N, Park YM, Ko KH. Breast Cancers Detected and Missed by AI-CAD: Results from the AI-STREAM Trial. Radiol Artif Intell. 2026 Jan;8(1):e250281. doi: 10.1148/ryai.250281. PMID 41147858
- DERIVEDChang YW, Ryu JK, An JK, Choi N, Park YM, Ko KH, Han K. Artificial intelligence for breast cancer screening in mammography (AI-STREAM): preliminary analysis of a prospective multicenter cohort study. Nat Commun. 2025 Mar 6;16(1):2248. doi: 10.1038/s41467-025-57469-3. PMID 40050619