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: 0
• Participant gender: Female

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%.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Margarita Louise Zuley
• Collaborator: National Cancer Institute (NCI)

Criteria

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 < 45.

• Subject has had a prior reaction to iodinated contrast; thus a known allergy to iodinated contrast