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

NCT07287111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 797

Last updated 2025-12-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

CadAI-B Dx

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.

Sponsors & Collaborators

  • BeamWorks Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2025-10-07
Completion
2025-11-24
FDA Device
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07287111 on ClinicalTrials.gov