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

NCT ID: NCT06428799

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-14
• Study Completion Date: 2024-04-24

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Carebot AI MMG

Intervention Type: 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 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.

Carebot AI MMG

Intervention Type: 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 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.

Carebot AI MMG

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Carebot s.r.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

EUC Mamocentrum Brno

Brno, , Czechia

Masaryk Memorial Cancer Institute

Brno, , Czechia

Hospital Šumperk

Šumperk, , Czechia

Countries

Czechia

Other Identifiers

00003

Identifier Type: -

Identifier Source: org_study_id