Title: Contrast Enhanced Mammography (CEM) to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
Principal Investigator: Margarita Zuley, MD
Total funding: $2,011,380 over 5 years
Annually in the US, more than 1 million breast biopsies are performed with less than 25% being cancer. This prospective study will enroll 1855 women and aims to evaluate if lack of enhancement on CEM can be used as a reliable indicator of benignity for findings detected and rated as low to intermediate suspicion (BIRADS 4A/4B) by mammogram, US and DBT. The primary expectation is that with CEM, biopsy recommendations for benign lesions will decrease significantly (~20%), while maintaining high NPV (>95%) and also maintaining high sensitivity for cancer detection. If the hypotheses are proven correct, this study could reduce biopsy rates for hundreds of thousands of women annually in this country alone.