Abstract
BackgroundUltrasound is the first and primary breast screening for thoes women with small and dense breast and is superior to mammography. BI-RADS using ultrasound causes approxinately over 40%-60% false-positive results, unnecessary biopsy and relatively low cancer-to biosy rate. This multi-center study in China is to determine whether contrast-enhanced ultrasound (CEUS) of the breast can improve the precision of BI-RADS. Methods1721 patients were enrolled at 8 sites in China. CEUS was performed before core needle biopsy or surgical resection and a revised BI-RADS classification was assigned based on CEUS performance. Using pathological results as golden standerd to evaluate the diagnostic performance of CEUS-based BI-RADS. Results1738 solid breast lesions (5.0-39.8mm, 17.89± 8.65mm) classified as BI-RADS 4 or 5 on conventional ultrasound or mammography. 771/1738(44.36%) are malignant and 967/1738(55.64%) are benign. The CEUS-based BI-RADS evaluation classified 402/1738 (23.13%) lesions into category 3 and its accuracy, sensitivity, specificity, positive and negative predictive values of 65.0%, 97.0%, 40.0%, 56.0% and 94.0%. The cancer-to-biopsy yield was 57.71% with CEUS-based BI-RADS 3 selected as the biopsy threshold compared with 44.36% otherwise, while the total biopsy rate was only 76.87% compared with 100% otherwiseand will reduce 39.5% (382/967) unnecessary biopsy rate in those benign nodules. Overall, only 2.59% of invasive cancers were misdiagnosed similar as BI-RADS 3 we use nowadays. ConclusionsThis study suggests that evaluation of BI-RADS 4 or 5 breast lesions with CEUS result in reduced biopsy rates and increased cancer-to-biopsy yields. Legal entity responsible for the studyJun Luo. FundingHas not received any funding. DisclosureThe author has declared no conflicts of interest.
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