Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound

BeamWorks Inc.797 enrolled

Overview

This is a retrospective, fully-crossed, multi-reader, multi-case (MRMC) study to evaluate the effectiveness of 'CadAI-B Dx' (CadAI-B) for decision support in breast ultrasound. The study compares the diagnostic performance of readers interpreting breast ultrasound images with and without the aid of CadAI-B. A total of 797 patient cases will be included, comprising 350 cases with a confirmed diagnosis of malignancy and 447 cases with a confirmed benign diagnosis. Sixteen readers will participate in the study to evaluate the device.

The study utilizes a crossover design where all readers independently review all cases. The control arm consists of a reading session where participating readers independently review cases without the assistance of the CadAI-B device (unaided reading). The experimental arm involves reading with CadAI-B assistance (AI-aided reading). To minimize potential bias, a washout period of four weeks will be maintained between the unassisted and assisted reading sessions for each reader. The primary hypothesis is that CadAI-B assistance significantly improves overall reader performance in breast ultrasound interpretation, as measured by the area under the Localization Receiver Operating Characteristic (LROC) curve (AULROC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

797

Conditions

Breast Cancer Breast Neoplasms

Interventions

CadAI-B DxDEVICE

CadAI-B Dx is a Software as a Medical Device (SaMD) designed to assist physicians by providing Computer-Aided Detection (CADe) and Diagnosis (CADx) capabilities in breast ultrasound interpretation. The software automatically processes the image to identify suspicious regions (Lesion Detection) and provides a quantitative malignancy score (CadAI-Score) mapped to a corresponding BI-RADS Category. It also analyzes lesion size and BI-RADS lexicon descriptors.

Eligibility

Sex: FEMALEMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women aged 22 years or older at the time of the breast ultrasound examination. 2. Standard B-mode breast ultrasound images available for analysis. 3. Lesions must have a confirmed diagnosis based on one of the following reference standards: 3-1. Malignant Cases: Diagnosis of breast cancer confirmed through biopsy or surgery. 3-2. Benign Cases: Confirmed as benign through biopsy or surgical excision, or confirmed as having no evidence of malignancy for at least 2 years of follow-up. Exclusion Criteria: 1. mages containing modes other than standard B-mode ultrasound, such as Doppler, elastography, or other annotations/overlays. 2. Patients who have breast implant(s). 3. Patients suffering from significant breast trauma or mastitis at the time of the breast ultrasound examination. 4. Images of post-surgical resection sites. 5. Images where multiple lesions are present within a single 2D ultrasound image

Locations (1)

Yonsei University Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Area Under the Localization Receiver Operating Characteristic (LROC) Curve (AULROC)

The difference in reader performance between the unaided and AI-aided sessions in breast ultrasound interpretation. LROC reflects both detection accuracy and localization precision. The primary hypothesis is that the mean AULROC of all readers for the AI-aided reading mode is greater than that for the unaided reading mode.