NCT06428799

Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment

Evaluation of Carebot AI MMG Medical Device for Detection and Radiographic Assessment of Breast Lesions and Quantitative Analysis of Breast Density: A Multicentric, Multi-Reader Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 122 (actual)
• Sponsor: Carebot s.r.o. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2) 1. Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS) 2. Comparison of Accuracy of Lesion Assessment by Clinician and DLAD (MASS, CLASS)

Detailed description

The mammography studies were acquired from three independent sites: Site 1 (EUC Mamocentrum Brno) and Site 2 (Hospital Šumperk, a.s.) specialise in routine screening mammography, and Site 3 (Masaryk Memorial Cancer Institute) is a comprehensive oncology facility primarily dedicated to diagnostic mammography, i.e. performing additional examinations in case of a suspicious finding (recall). The ground truth was obtained by consensus of two board-certified radiologists with expertise in radiology and diagnostic methods, and 13 and 27 years of experience with mammography image interpretation, respectively. For comparative analysis, a team of five independent radiologists with clinical experience in interpreting mammography images was established. Three of the clinicians were junior (2, 2, and 4 years of experience, respectively) without board-certification; two physicians were senior (7 and 8 years of experience, respectively), board-certified.

Conditions

• Breast Cancer
• Breast Tumor Benign

Interventions

Type	Name	Description
DEVICE	Carebot AI MMG	Carebot AI MMG is a software solution that utilizes artificial intelligence methods, specifically deep learning and computer vision algorithms, to evaluate and localize suspicious regions of potential lesions during the interpretation of digital breast x-rays as part of standard mammography screening procedures. The Carebot AI MMG medical device is not intended for use in diagnostic mammography. The Carebot AI MMG is intended for use in women over the age of 18. The predictive outputs of the Carebot AI MMG medical device are intended to aid decision-making in screening clinical practice, always in conjunction with other relevant patient information and based on the professional judgment of the examining clinician. The Carebot AI MMG is specifically designed to provide a supporting layer of analysis that helps in evaluating or prioritizing mammography images with additional patient information and the professional judgment of the examining physician.

Timeline

• Start date: 2022-01-14
• Primary completion: 2024-04-24
• Completion: 2024-04-24
• First posted: 2024-05-24
• Last updated: 2026-03-18

Locations

3 sites across 1 country: Czechia