CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
Status:
Not yet recruiting
Trial end date:
2026-11-01
Target enrollment:
Participant gender:
Summary
One of the primary criticisms of mammography is that it leads to unneeded stress and anxiety
from identification and biopsy of non-cancerous findings. Contrast-enhanced mammography (CEM)
has the potential to significantly reduce biopsy rates for commonly seen benign breast
lesions while preserving very high cancer detection. The investigators propose a prospective
clinical study of patients with diagnostic mammograms rated as BIRADS 4A or 4B and scheduled
for a biopsy, in which, prior to undergoing their scheduled biopsy, a CEM procedure is
performed. The investigators will test the primary hypothesis that for soft tissue lesions
(i.e. masses, asymmetries, architectural distortions) initially rated BI-RADS 4A/4B adding
CEM will reduce, by at least 20%, the number of biopsy recommendations for actually benign
cases and, at the same time, provide a negative predictive value (NPV) higher than 95%.