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ACTIVE NOT RECRUITING
NCT06622967
NA

KNUCH CadAI-B-1(KCB-1)

Sponsor: JeeYeon Lee

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-09-15

Completion Date

2024-12-31

Last Updated

2024-10-02

Healthy Volunteers

No

Interventions

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.

Locations (1)

Kyungpook National University Chilgok Hospital

Daegu, South Korea