Contrast Enhanced Mammography (CEM) to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
Margarita Louise Zuley
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%.
Description
The investigators believe that an operationally simple, cost effective, contrast enhanced mammogram (CEM), performed during the patient's diagnostic evaluation, would be the best approach to improve the accuracy of radiologists' decisions for need to biopsy lesions classified with mammography, tomosynthesis (DBT) or ultrasound as 4A or 4B. CEM uses iodine contrast with dual low and high KeV mammogram images to create a contrast enhancement map of the breast that directly overlays the mammogram, thus providing anatomic and kinetic information, similar to MRI. The investigators found in a prelim…
Eligibility
- Age range
- 30+ years
- Sex
- Female
- Healthy volunteers
- Yes
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 kno…
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
Location
- UPMC Magee-Womens HospitalPittsburgh, Pennsylvania