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| ID | Type | Description | Link |
|---|---|---|---|
| Digital healthcare demonstrati | Other Identifier | Daegu Gyeongbuk Medical Innovation Foundation |
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| Name | Class |
|---|---|
| Kyungpook National University Chilgok Hospital | OTHER |
| BeamWorks Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CadAI-B intervention group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CadAI-B | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion and Per-patient Diagnostic Performance | AUC (Area Under the Curve), Sensitivity, Specificity | At the end of the trial, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion and Per-patient Detection Performance | Sensitivity, Specificity | At the end of the trial, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BeamWorks Usability Evaluation Scale (Score of BeamWorks System Usability Scale (SUS)) | 12~30 : Unacceptable, 30~40 :Marginal, >40:Acceptable | At the end of the trial, up to 6 months |
Inclusion Criteria:
Exclusion Criteria:
Only female
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| Name | Affiliation | Role |
|---|---|---|
| Jeeyeon Lee, MD, PhD | Kyungpook National University Chilgok Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Chilgok Hospital | Daegu | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |