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Diagnostic Accuracy of Carebot AI MMG in Mammography Screening: Multicenter MRMC Study

NCT07298252 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 222

Last updated 2026-01-14

No results posted yet for this study

Summary

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

  • Breast Neoplasms
  • Breast Cancer Detection
  • Breast Cancer - Female
  • Breast Cancer Screening

Interventions

DEVICE

Carebot AI MMG software analysis

Retrospective stand-alone AI analysis of anonymized 2D full-field digital mammography (FFDM) examinations. The AI system (Carebot AI MMG, version 2.9) processes existing images and outputs case-level risk classifications; no additional imaging, randomization, or changes to patient management occur as part of this study.

Sponsors & Collaborators

  • Carebot s.r.o.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-11-03
Completion
2025-11-03

Countries

  • Czechia
  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07298252 on ClinicalTrials.gov