Clinical trial · Interventional
Screening Mammography: Single Reading by One Radiologist With AI vs. Double Reading by Two Radiologists (AI-BCSQ)
Use of Artificial Intelligence in Breast Cancer Screening: Impact of AI-Assisted Single Reading by One Radiologist on Screening Quality Indicators Compared to Standard Double Reading by Two Radiologists Without AI
NCT07075679CI-TRIAL-00107092AI-BCSQrecruitingN/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)
A randomized prospective study comparing the evaluation of mammography images in a breast cancer screening programme by a single radiologist with AI support versus standard double reading by two radiologists without AI support.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence (AI) | — | UNRESOLVED | — |
| Breast Cancer Screening | — | UNRESOLVED | — |
| Breast Cancer Screening and Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group with AI iCAD version 3 | Diagnostic Test | — | UNRESOLVED |
| Group without AI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group with AI
- description
- Asymptomatic women aged 45-69 participating in breast cancer screening programme, reading of mammograms by one radiologist with AI support.
- interventionNames
- Diagnostic Test: Group with AI iCAD version 3
- type
- OTHER
- label
- Group without AI
- description
- Asymptomatic women aged 45-69 participating in breast cancer screening programme, reading of mammograms by two radiologists without AI (current practice).
- interventionNames
- Diagnostic Test: Group without AI
Primary outcomes (1)
- measure
- Further assessment rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * age 45-69, asymptomatic woman participating in breast cancer screening programme Exclusion Criteria: * clinical signs of breast disease - indication for diagnostic mammography
References
Publications (12)
- BACKGROUNDLarsen M, Olstad CF, Lee CI, Hovda T, Hoff SR, Martiniussen MA, Mikalsen KO, Lund-Hanssen H, Solli HS, Silberhorn M, Sulheim AO, Auensen S, Nygard JF, Hofvind S. Performance of an Artificial Intelligence System for Breast Cancer Detection on Screening Mammograms from BreastScreen Norway. Radiol Artif Intell. 2024 May;6(3):e230375. doi: 10.1148/ryai.230375. PMID 38597784
- RESULTLambin P, Leijenaar RTH, Deist TM, Peerlings J, de Jong EEC, van Timmeren J, Sanduleanu S, Larue RTHM, Even AJG, Jochems A, van Wijk Y, Woodruff H, van Soest J, Lustberg T, Roelofs E, van Elmpt W, Dekker A, Mottaghy FM, Wildberger JE, Walsh S. Radiomics: the bridge between medical imaging and personalized medicine. Nat Rev Clin Oncol. 2017 Dec;14(12):749-762. doi: 10.1038/nrclinonc.2017.141. Epub 2017 Oct 4. PMID 28975929
- RESULTTudos Z, Veverkova L, Baxa J, Hartmann I, Ctvrtlik F. The current and upcoming era of radiomics in phaeochromocytoma and paraganglioma. Best Pract Res Clin Endocrinol Metab. 2025 Jan;39(1):101923. doi: 10.1016/j.beem.2024.101923. Epub 2024 Aug 23. PMID 39227277
- RESULTMcDonald ES, Conant EF. Can AI Reduce the Harms of Screening Mammography? Radiol Artif Intell. 2023 Oct 25;5(6):e230304. doi: 10.1148/ryai.230304. eCollection 2023 Nov. No abstract available. PMID 38074781
- RESULTLetter H, Peratikos M, Toledano A, Hoffmeister J, Nishikawa R, Conant E, Shisler J, Maimone S, Diaz de Villegas H. Use of Artificial Intelligence for Digital Breast Tomosynthesis Screening: A Preliminary Real-world Experience. J Breast Imaging. 2023 May 22;5(3):258-266. doi: 10.1093/jbi/wbad015. PMID 38416890
- RESULTDahlblom V, Dustler M, Tingberg A, Zackrisson S. Breast cancer screening with digital breast tomosynthesis: comparison of different reading strategies implementing artificial intelligence. Eur Radiol. 2023 May;33(5):3754-3765. doi: 10.1007/s00330-022-09316-y. Epub 2022 Dec 11. PMID 36502459