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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Neoplasms
• Intervention / Treatment: Device: CadAI-B Dx

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).

• Study Type: Interventional
• Enrollment (Actual): 797
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 03722
    • Yonsei University Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CadAI- Dx(AI) Unaided Reading; Readers evaluate each ultrasound image without access to AI assistance. Readers use only the provided radiological images and their professional clinical expertise to determine their final diagnosis and relevant findings
Experimental: CadAI-DX (AI)-aided Reading; Readers have access to CadAI-B's decision-support outputs, which include a pixel-level heatmap (CadAI-Map), auto-segmented lesion boundary, BI-RADS lexicon descriptors, a suggested malignancy probability score (CadAI-Score), and BI-RADS category.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, approximately 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Comparison of the average sensitivity of the readers between the unaided and AI-aided sessions.	Through study completion, approximately 2 months
Positive Predictive Value (PPV)	Comparison of PPV between unaided and AI-aided sessions. The PPV will be adjusted for disease prevalence in the target population to reflect real-world clinical practice.	Through study completion, approximately 2 months
Negative Predictive Value (NPV)	Comparison of NPV between unaided and AI-aided sessions. The NPV will be adjusted for disease prevalence in the target population.	Through study completion, approximately 2 months
Inter-reader Agreement	Evaluation of the consistency of interpretations among different readers. Inter-reader agreement for BI-RADS category and descriptors assignments will be compared between sessions using Kappa statistics.	Through study completion, approximately 2 months
Reading Time	Comparison of the average reading time per case between the unaided and AI-aided sessions to assess if the AI system improves the efficiency of interpretation.	Through study completion, approximately 2 months
AI-Ground Truth Agreement	Assessment of the agreement between the AI system's outputs and the ground truth. This includes agreement on BI-RADS categories and descriptors (using Kappa statistics) and lesion size measurements (using Intraclass Correlation Coefficient).	Through study completion, approximately 2 months

Collaborators and Investigators

• Sponsor: BeamWorks Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2025
• Primary Completion (Actual): October 7, 2025
• Study Completion (Actual): November 24, 2025

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: IP0014-US-CAB-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: ndividual participant data will not be shared to protect proprietary information and subject confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes