RECRUITINGPhase 4INTERVENTIONAL

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

About This Trial

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%.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Subject is unable or unwilling to undergo willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

contrast 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

DRUG

Iodinated Contrast Media (ICM)

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

Locations (1)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States