Status:
RECRUITING
CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
Lead Sponsor:
Margarita Louise Zuley
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
30+ years
Phase:
PHASE4
Brief 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 poten...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
2100 Patients enrolled
Trial Details
Trial ID
NCT05206331
Start Date
February 1 2022
End Date
November 30 2027
Last Update
October 8 2025
Active Locations (1)
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1
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213