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

NCT06428799 | Completed

• 1 other identifier: CB-MMG-01-MC
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 3

Brief Summary

Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2)

1. 1.Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS)
2. 2.Comparison of Accuracy of Lesion Assessment by Clinician and DLAD (MASS, CLASS)

Conditions

Breast Cancer; Breast Tumor Benign

Outcome Measures

Primary Outcomes (1)

• Performance Test

  A multicenter, multi-reader, retrospective study was designed to validate the clinical efficacy of the proposed Carebot AI MMG (also referred to as "DLAD"). Using a non-certified medical device, a test set of retrospectively collected mammography studies in standard projections (CC and MLO). The performance of the DLAD was evaluated against the ground truth for individual indications (breast density evaluation, breast lesion detection) using Accuracy.

  2024

Secondary Outcomes (2)

• Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Density Assessment

  2024

• Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Lesion Detection

  2024

Study Arms (3)

Retrospective collection of DICOM patient files for Site 1

A total of 60 mammographic studies were retrospectively collected from Site 1 (EUC Mamocentrum Brno). The acquisition of mammography studies from Site 1 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 14 January 2022.

Device: Carebot AI MMG

Retrospective collection of DICOM patient files for Site 2

A total of 28 mammographic studies were retrospectively collected from Site 2 (Hospital Šumperk, a.s.). The acquisition of mammography studies from Institution 2 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 31 January 2023.

Device: Carebot AI MMG

Retrospective collection of DICOM patient files for Site 3

A total of 34 mammographic studies were retrospectively collected from Site 3 (Masaryk Memorial Cancer Institute). The acquisition of mammography studies from Institution 3 was enabled by the amendment to the contract for the transfer of X-ray images for medical research purposes, signed on 21 February 2023, which follows the contract for the transfer of X-ray images for medical research purposes, signed on 3 January 2022.

Device: Carebot AI MMG

Interventions

Carebot AI MMG DEVICE

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.

Retrospective collection of DICOM patient files for Site 1; Retrospective collection of DICOM patient files for Site 2; Retrospective collection of DICOM patient files for Site 3

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The medical device cannot be used in male breast examination.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 122 mammography studies (488 images, the so-called "test data") were obtained from the reference sites for the evaluation by radiologists and the Carebot AI MMG v2.2. The target sites used different mammography X-ray machines: Site 1 and Site 2 used the Senographe Essential mammography machine from GE HealthCare to image patients, and Site 3 used the Selenia Dimensions mammography machine from Hologic and the MAMMOMAT Revelation mammography machine from Siemens Healthineers.

You may qualify if:

• The medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography.

You may not qualify if:

• The medical device cannot be used in patients with breast implants.
• The medical device cannot be used in male breast examination.
• The medical device cannot be used in patients under 18 years of age.

Sponsors & Collaborators

• Carebot s.r.o.: lead

Study Sites (3)

EUC Mamocentrum Brno

Brno, 60200, Czechia

Location

Masaryk Memorial Cancer Institute

Brno, 60200, Czechia

Location

Hospital Šumperk

Šumperk, 78701, Czechia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 24, 2024
• Study Start: January 14, 2022
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CZ (3)