Department of Radiology, Seoul National University Hospital
Seoul, 110-744, South Korea
NCT Number: NCT01910103
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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Notify Me20 year and older
Female
Observational
Seoul, 110-744, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: one year
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.
Time frame: One year
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.
Seoul National University Hospital
Other
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