Actively Recruiting
CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
Led by Margarita Louise Zuley · Updated on 2025-10-08
2100
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
Sponsors
M
Margarita Louise Zuley
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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%.
CONDITIONS
Official Title
CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is female of any race and ethnicity
- Subject is �30 years old or older
- Subject is diagnosed with a suspicious breast abnormality and is scheduled for an imaging directed breast biopsy.
You will not qualify if you...
- 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; known allergy to iodinated contrast
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Suzanne Burdin, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here