KNUCH CadAI-B-1(KCB-1)

Multinational Clinical Trial of Real-time Artificial Intelligence System (CadAI-B) for Breast Ultrasound: Prospective Clinical Validation Study

The CadAI-B (Computer Aided Design Artificial Intelligence-Breast) system is a real-time AI diagnostic tool for breast ultrasound. It integrates with ultrasound devices to detect suspicious lesions, providing size, BI-RADS, and malignancy probability. After installation and user training, the system displays real-time breast conditions and automatically analyzes lesions when a freeze frame is set, showing results in seconds. This study will assess CadAI-B's accuracy and reliability by comparing its findings with biopsy results.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Neoplasm; Female
• Intervention / Treatment: Diagnostic test: CadAI-B

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Kyungpook National University Chilgok Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Women aged 20 years or older
• Individuals scheduled to undergo breast ultrasound for diagnostic evaluation
• Patients whose Ground Truth can be determined through biopsy, surgery, or follow-up

Exclusion Criteria:

• Images containing artifacts that may affect the interpretation
• Presence of breast implants
• Significant breast trauma or mastitis at the time of the breast ultrasound that could cause distortion in image interpretation
• History of surgery or chemotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CadAI-B intervention group; Participants in this arm will receive the CadAI-B system for the detection of lesions. The AI-based tool will assist healthcare professionals in identifying lesions through enhanced image analysis.

Diagnostic test: CadAI-B; The ultrasound is performed following the usual process. If there are any lesions or areas of concern identified by the patient, a more detailed analysis is conducted on the affected area. When a lesion is confirmed, the examiner verifies the results through the frozen image, while also securing the results displayed on CadAI-B. The examiner uses the analysis from CadAI-B as a reference to make the final BI-RADS classification. Static images and cine clips are captured from the most suspicious areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion and Per-patient Diagnostic Performance	AUC (Area Under the Curve), Sensitivity, Specificity	At the end of the trial, up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion and Per-patient Detection Performance	Sensitivity, Specificity	At the end of the trial, up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BeamWorks Usability Evaluation Scale (Score of BeamWorks System Usability Scale (SUS))	12~30 : Unacceptable, 30~40 :Marginal, >40:Acceptable	At the end of the trial, up to 6 months

Collaborators and Investigators

• Sponsor: JeeYeon Lee
• Collaborators: Kyungpook National University Chilgok Hospital; BeamWorks Inc.
• Investigators: Study Chair: Jeeyeon Lee, MD, PhD, Kyungpook National University Chilgok Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; breast neoplasm
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: KNUCH IRB number : 2024-05-026; Digital healthcare demonstrati (Other Identifier: Daegu Gyeongbuk Medical Innovation Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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