Semiautonomous Deep Learning Breast Cancer Rule-out System for Screening Mammography
2025-11-29https://doi.org/10.1148/atlas.1764446602310
81
Overview
Schema Version
https://atlas.rsna.org/schemas/2025-11/model.json
Name
Semiautonomous Deep Learning Breast Cancer Rule-out System for Screening Mammography
Link
https://dx.doi.org/10.1148/ryai.230033
Indexing
Keywords: Artificial Intelligence, Semiautonomous Deep Learning, Breast Cancer, Screening Mammography, Rule-out system, False-positive reduction
Content: BR
RadLex: RID36027, RID45682, RID10357
Author(s)
Stefano Pedemonte
Trevor Tsue
Brent Mombourquette
Yen Nhi Truong Vu
Thomas Matthews
Rodrigo Morales Hoil
Meet Shah
Nikita Ghare
Naomi Zingman-Daniels
Susan Holley
Catherine M. Appleton
Jason Su
Richard L. Wahl
Organization(s)
Whiterabbit.ai
Onsite Women's Health
SSM Health
Mallinckrodt Institute of Radiology, Washington University School of Medicine
Royal Surrey NHS Foundation Trust (OPTIMAM project team)
Version
1.0
License
Text: CC BY 4.0
URL: https://creativecommons.org/licenses/by/4.0/
Contact
ia.tibbaretihw@hcraeser
Funding
Supported by Whiterabbit.ai. Washington University in St. Louis has equity interests in Whiterabbit.ai and may receive royalty income and milestone payments per an agreement with Whiterabbit.ai to develop the technology.
Ethical review
IRB approvals obtained; informed consent waived; data handled according to HIPAA.
Date
Updated: 2024-05-01
Published: 2024-04-10
Created: 2023-02-02
References
[1] Pedemonte S, Tsue T, Mombourquette B, et al.. "A Semiautonomous Deep Learning System to Reduce False Positives in Screening Mammography". Radiology: Artificial Intelligence. 2024;6(3):e230033.. 2024-04-10. doi:10.1148/ryai.230033. PMID: 38597785. PMCID: PMC11140506.
Model
Architecture
Two-stage deep learning system: low-level vision model analyzes each mammogram image independently; high-level vision metamodel integrates multi-view, bilateral, and prior imaging along with age and prior BI-RADS assessments to produce an exam-level malignancy probability.
Clinical benefit
Reduces screening mammograms requiring radiologist interpretation, decreases false-positive callbacks and benign biopsies while maintaining cancer detection rate within a predefined noninferiority margin.
Clinical workflow phase
Patients’ triage; workflow optimization; clinical decision support for screening mammography.
Decision threshold
Rule-out operating threshold selected on validation data to achieve target 12-month sensitivity of 99% (and alternatively 97%). Exams with scores below threshold are assigned BI-RADS 1 by the device.
Degree of automation
Semiautonomous rule-out: automatically assigns BI-RADS 1 to a subset of nonsuspicious screening exams; remaining exams proceed to standard radiologist interpretation.
Indications for use
Identification of screening mammograms not suspicious for breast cancer in a screening population, to reduce radiologist workload and false-positive downstream events in screening programs (US and UK settings).
Input
2D full-field digital mammography images (multi-view, bilateral), patient age, prior mammogram images, and prior exam BI-RADS assessments when available.
Instructions
Device reads examinations before radiologists. Exams with prediction below the rule-out threshold are automatically labeled BI-RADS 1 (negative) and removed from radiologist workflow; all others are read by radiologists as usual. Site- and scanner-specific operating point selection may be considered.
Limitations
Retrospective simulation; assumes radiologist behavior unaffected by removal of exams. Performance varies by scanner model (HSE vs SED) due to training data imbalance. Limited tracking of false negatives in one dataset (US2). Test sets include multiple exams per patient which may underestimate variance. Radiologist false negatives include interval cancers likely not visible at screening. Prospective reader studies and QA/monitoring systems are needed.
Output
CDEs: RDE858
Description: Exam-level malignancy probability and binary rule-out decision; for scores below threshold, assigned BI-RADS 1 (nonsuspicious) versus send to radiologist.
Recommendation
Operate at high-sensitivity rule-out thresholds; consider site/scanner model when selecting operating point; further prospective validation and QA monitoring recommended.
Reproducibility
Evaluation conducted on retrospective datasets with specified splits; performance reported with prevalence adjustments, noninferiority tests, and bootstrap CIs. Code not provided.
Use
Intended: Detection and diagnosis
Out-of-scope: Detection and diagnosis
Excluded: Other
User
Intended: Subspecialist diagnostic radiologist, Administrator
Out-of-scope: Layperson
Excluded: Patient, Layperson