This phase III trial investigates how a contrast-enhanced mammogram works in improving screening of women with a history of breast cancer who may be inadequately scanned by mammography alone. The contrast enhancement consists of injecting an iodine-containing “dye” into the bloodstream that allows researchers to better see masses that may represent cancer in the breasts. Results of this study may indicate earlier breast cancer detection and less invasive treatment than if the cancer were detected as part of usual care.
Additional locations may be listed on ClinicalTrials.gov for NCT04085510.
Locations matching your search criteria
United States
Pennsylvania
Erie
UPMC Hillman Cancer Center ErieStatus: Active
Contact: Wendie A. Berg
Phone: 412-641-6656
Pittsburgh
UPMC-Magee Womens HospitalStatus: Active
Contact: Wendie A. Berg
Phone: 412-641-6656
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Contact: Wendie A. Berg
Phone: 412-641-6656
PRIMARY OBJECTIVE:
I. To show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives.
SECONDARY OBJECTIVE:
I. Complete a reader validation study at the conclusion of accrual (planned for year 2 of this project).
OUTLINE:
Within 8 weeks of standard of care (SOC) digital tomosynthesis mammography (preferably on the same day), patients receive iopamidol intravenously (IV), then undergo bilateral contrast-enhanced imaging (CEM) over 8-15 minutes.
After completion of study, patients are followed up for 1 year.
Lead OrganizationUPMC-Magee Womens Hospital
Principal InvestigatorWendie A. Berg
