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| ID | Type | Description | Link |
|---|---|---|---|
| RS-2023-00227526 | Other Grant/Funding Number | Korea Ministry of Science and ICT |
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| Name | Class |
|---|---|
| Severance Hospital | OTHER |
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The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination
CadAI-B for Breast is a real-time AI diagnosis system designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. The primary objective of the study is to evaluate the effectiveness of CadAI-B in the assistance of detection and diagnosis of breast cancer by comparing the clinical performance of physicians before and after using CadAI-B in their ultrasound reading. The secondary objective of this study is to evaluate the sensitivity and specificity using CadAI-B for US examinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer group | confirmed as a breast cancer (DCIS or invasive cancer) through the subsequent biopsy conducted within following 1 year of the ultrasound exam. |
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| Benign group | Either confirmed as a benign through the subsequent biopsy conducted within following 1 year of the ultrasound exam or showing stability on more than 2 years of imaging follow-up after initial diagnosis |
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| Normal group | Interpreted as BI-RADS 1 (Negative) with no cancers on the ultrasound exam |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CadAI-B for Breast | Device | CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the LROC Curve | The area under the LROC curve (AUC_LROC) on the diagnosis of suspicious lesions was computed and compared between the aided and unaided sessions. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion detection sensitivity and specificity | The mean sensitivity and specificity of 15 readers were calculated and compared between the aided and unaided sessions. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Mainly recruited from a tertiary hospital but no limitation of enrollment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Severance Hospital | Seoul | 03722 | 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 |