This clinical trial studies whether contrast enhanced mammography (CEM) helps doctors identify cancerous breast abnormalities in patients undergoing breast biopsy for suspicious abnormalities or lesions. A standard mammogram is an x-ray of the breast which produces two-dimensional (2D) images. CEM is similar in nature to a standard 2D mammogram. The contrast enhancement during a CEM consists of injecting a "dye" into the bloodstream before the 2D mammogram that allows doctors to better see the tissue structures in the breasts. Contrast enhancement is commonly used in other imaging techniques, such as contrast enhanced magnetic resonance imaging and contrast enhanced computed tomography. CEM may be effective in helping doctors identify cancerous breast abnormalities in patients undergoing breast biopsy for suspicious abnormalities or lesions.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05206331.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Contact: Margarita Louise Zuley
Phone: 412-641-4709
PRIMARY OBJECTIVES:
I. To assess the ability of contrast enhanced mammography (CEM) to predict benignity versus malignancy in a population of patients scheduled to undergo imaging guided breast biopsies for a suspicious breast abnormality with the goal of assessing an overall diagnostic accuracy as measured by sensitivity and specificity, and negative and positive predictive values.
II. Examine how artificial intelligence (AI) breast cancer detection tools interacts with CEM.
OUTLINE:
Patients receive iopamidol intravenously (IV) and then undergo CEM over 15-60 minutes prior to scheduled diagnostic exam or biopsy. Patients may also undergo blood and/or urine sample collection during screening.
After completion of study intervention, patients are followed up for 1 year.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorMargarita Louise Zuley