NCT07287111

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

Multi-Reader Multi-Case, Cross-Over, Retrospective Study to Evaluate the Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 797 (actual)
• Sponsor: BeamWorks Inc. · Industry
• Sex: Female
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Breast Cancer
• Breast Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-30
• Primary completion: 2025-10-07
• Completion: 2025-11-24
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study