KNUCH CadAI-B-1(KCB-1)
Not Applicable
Active, not recruiting
- Conditions
- Breast NeoplasmFemale
- 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
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
- 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
Kyungpook National University Chilgok Hospital🇰🇷Daegu, Korea, Republic of