Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast

BeamWorks

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Device: CadAI-B for Breast

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06352684

RS-2023-00227526 (Other Grant/Funding Number)

DP0001-SEV-CAB-II

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination

Full description

CadAI-B for Breast is a real-time AI diagnosis system designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. The primary objective of the study is to evaluate the effectiveness of CadAI-B in the assistance of detection and diagnosis of breast cancer by comparing the clinical performance of physicians before and after using CadAI-B in their ultrasound reading. The secondary objective of this study is to evaluate the sensitivity and specificity using CadAI-B for US examinations.

Enrollment: 1,000 patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women who underwent breast US examination
• Women with breast cancer (DCIS or invasive cancer) diagnosed via biopsy
• Women who had been followed for more than 2 years after initial US examination

Exclusion criteria

• women who had breast implants
• women who had US images containing artifacts affecting the review of images

Trial design

1,000 participants in 3 patient groups

Cancer group

Description:

confirmed as a breast cancer (DCIS or invasive cancer) through the subsequent biopsy conducted within following 1 year of the ultrasound exam.

Treatment:

Device: CadAI-B for Breast

Benign group

Description:

Either confirmed as a benign through the subsequent biopsy conducted within following 1 year of the ultrasound exam or showing stability on more than 2 years of imaging follow-up after initial diagnosis

Treatment:

Device: CadAI-B for Breast

Normal group

Description:

Interpreted as BI-RADS 1 (Negative) with no cancers on the ultrasound exam

Treatment:

Device: CadAI-B for Breast