KNUCH CadAI-B-1(KCB-1)

JeeYeon Lee

Status: Active, not recruiting

Conditions: Breast Neoplasm; Female

Treatments: Diagnostic Test: CadAI-B

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06622967

Digital healthcare demonstrati (Other Identifier)

KNUCH IRB number : 2024-05-026

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

CadAI-B intervention group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: CadAI-B