Clinical trial · Observational
Diagnostic Accuracy of Carebot AI MMG in Mammography Screening: Multicenter MRMC Study
Retrospective Multicenter Multi-Reader, Multi-Case Diagnostic Accuracy Study of Carebot AI MMG Compared With Radiologists on 2D Full-Field Digital Mammography in Breast Cancer Screening
- 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 study evaluates the diagnostic performance of Carebot AI MMG, an artificial intelligence (AI)-enabled medical device for evaluating mammograms. The software analyzes standard full-field digital mammography (FFDM) images and classifies each examination as having no suspicious finding ("Low Risk"), a probably benign mass ("Medium Risk"), or a suspicious malignant mass ("High Risk"). The study is retrospective and observational. It uses anonymized mammography examinations from four screening centers, without any additional imaging or contact with patients. Three experienced breast radiologists independently read the same set of cases, and their assessments are used as the human benchmark. A histopathology-based reference standard, supplemented by radiologist consensus and follow-up information for negative cases, is used to determine whether cancer is present. The main goal is to compare the AI system with human radiologists in terms of sensitivity and specificity for detecting breast cancer, and to assess whether the AI can achieve non-inferior performance at two predefined operating points: one favoring higher sensitivity and negative predictive value (rule-out) and one favoring higher specificity and positive predictive value (rule-in).
Conditions
Conditions (4)
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 Detection | — | UNRESOLVED | — |
| Breast Cancer - Female | — | UNRESOLVED | — |
| Breast Cancer Screening | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carebot AI MMG software analysis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Malignant cases
- description
- Women with biopsy-proven breast cancer included in the analytical subset (n = 48). Each case corresponds to a screening full-field digital mammography (FFDM) examination with all four standard views (LCC, RCC, LMLO, RMLO), retrospectively identified from participating screening centers.
- interventionNames
- Device: Carebot AI MMG software analysis
- label
- Non-malignant cases
- description
- Women without histopathological evidence of breast cancer, classified as negative or stably benign by two independent local radiologists with at least 2 years of imaging follow-up (n = 174). Each case corresponds to a screening FFDM examination with all four standard views (LCC, RCC, LMLO, RMLO), retrospectively selected from the same screening population.
- interventionNames
- Device: Carebot AI MMG software analysis
Primary outcomes (2)
- measure
- Balanced accuracy (BA) of Carebot AI MMG for detecting malignant versus non-malignant examinations
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female sex * Age ≥ 18 years at the time of the screening mammogram * Screening full-field digital mammography (FFDM) examination with all four standard views (LCC, RCC, LMLO, RMLO) available * Sufficient image quality and complete DICOM metadata to allow retrospective analysis Exclusion Criteria: * Male sex * Age \< 18 years * Digital breast tomosynthesis (DBT/3D) examinations without a corresponding full 2D FFDM four-view series * Incomplete mammography series (missing one or more of LCC, RCC, LMLO, RMLO) * Corrupted or unreadable DICOM files * Missing or inconsistent key metadata (e.g., laterality, view, acquisition date)
References
Publications (0)
Data not yet available