KNUCH CadAI-B-1(KCB-1)

Not Applicable

Active, not recruiting

• Conditions: Breast Neoplasm; Female
• Interventions: Diagnostic Test: CadAI-B

• Registration Number: NCT06622967
• Lead Sponsor: JeeYeon Lee

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-15
• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CadAI-B intervention group	CadAI-B	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Lesion and Per-patient Detection Performance	At the end of the trial, up to 6 months	Sensitivity, Specificity

Trial Locations

Locations (1)

Kyungpook National University Chilgok Hospital; 🇰🇷 Daegu, Korea, Republic of