CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study

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%.

Eligibility

Inclusion Criteria:

* Subject is female of any race and ethnicity
* Subject is ≥30 years old
* Subject is diagnosed with a suspicious breast abnormality and is scheduled for an imaging directed breast biopsy.

Exclusion Criteria:

* Subject is unable or unwilling to undergo informed consent
* Subject has a breast implant in the breast of interest
* Subject is pregnant
* Subject is breast-feeding
* Subject is actively being treated for cancer of any type with chemotherapy
* Subject has reduced kidney function with eGFR \< 30.
* Subject has had a prior reaction to iodinated contrast; thus a known allergy to iodinated contrast

Conditions2

Locations1 site

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