Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment (EMBLEDDA-MMG)

Carebot s.r.o.

Status: Completed

Conditions: Breast Cancer; Breast Tumor Benign

Treatments: Device: Carebot AI MMG

Study type: Observational

Funder types: Industry

Identifiers

NCT06428799

00003

Details and patient eligibility

About

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)

Full 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.

Enrollment: 122 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

122 participants in 3 patient groups

Retrospective collection of DICOM patient files for Site 1

Description:

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.

Treatment:

Device: Carebot AI MMG

Retrospective collection of DICOM patient files for Site 2

Description:

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.

Treatment:

Device: Carebot AI MMG

Retrospective collection of DICOM patient files for Site 3

Description:

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.

Treatment:

Device: Carebot AI MMG