RecruitingPhase 4NCT05206331

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

Contrast Enhanced Mammography (CEM) to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study

Sponsor

Margarita Louise Zuley

Enrollment

2,100 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 30 Years

Inclusion Criteria3

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 Criteria7

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

Interventions

DEVICEcontrast enhanced mammography

Dual-energy contrast images; low-energy CEM images will be obtained with a kilovoltage below 35 kVp while the high-energy images will be obtained with 45-49 kVp.The average glandular dose of the CEM procedure is approximately 2.44 mGy per view

DRUGIodinated Contrast Media (ICM)

standard FDA-approved low osmolarity Iodine contrast agent with 350-370 mg/ml