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Diagnostic performance of digital breast tomosynthesis (DBT) would be not inferior to the that of breast ultrasound in women with dense breast.
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance (AUC: area of under ROC curve) of DBT and US | The primary endpoint will be an analysis of the diagnostic performance of DBT to that of US for detecting breast cancer in the screening and diagnostic setting. The hypothesis is that DBT is not inferior to US for detecting breast cancer. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic sensitivity, sensitivity, negative predictive value, and positive predictive value of DBT and US for detecting breast cancer. | We will calculate diagnostic sensitivity (%), sensitivity (%), negative predictive value (%), and positive predictive alue (%) of the DBT and US for the detection of breast cancer on a per-patient basis by using a BI-RADS score of 4 or 5 considered as test-positive and a BI-RADS score of 1, 2, or 3 considered as test-negative. Cases of women undergoing biopsy with malignant disease results were considered disease-positive. Cases of women with concordant benign biopsy results and women not undergoing biopsy with no evidence of breast malignancy after 1 year of clinical follow-up were considered diase-negative. |
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Inclusion Criteria:
Exclusion Criteria:
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Women undergoing mammography and breast US for screening or diagnostic purpose
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| Name | Affiliation | Role |
|---|---|---|
| Jung Min Chang, M.D., Ph.D. | Department of Radiology, Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiology, Seoul National University Hospital | Seoul | 110-744 | 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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| One year |
| D017437 |
| Skin and Connective Tissue Diseases |