NCT06622967

KNUCH CadAI-B-1(KCB-1)

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: JeeYeon Lee · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Neoplasm
• Female

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-15
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2024-10-02
• Last updated: 2024-10-02

Locations

1 site across 1 country: South Korea