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Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)
This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.
The investigators seek to determine if improved breast cancer detection is maintained with biennial contrast-enhanced mammography (CEM) added to annual digital breast tomosynthesis (DBT) with overall fewer false positives than from annual DBT plus CEM. The investigators will offer biennial CEM exams for eligible patients. Enrolled participants will have a baseline CEM exam with their routine DBT exam, and then have another CEM exam 24 months after their baseline CEM exam and then again at 48 months. Participants will continue to have their annual DBT exams during this time as a part of their usual care. Two radiologists (one primary) will evaluate each pair of examinations by sequentially interpreting each of DBT and CEM in opposing order (primary reader DBT then CEM and secondary reader CEM then DBT), initially blinded to the other modality. We expect that with biennial screening, at least a similar number of cancers will be detected with CEM (and possibly more that were occult on the DBT-only screen 12 months prior), with a similar incremental false-positive rate and at least similar (if not improved) overall positive predictive value (PPV1).
Age
30 - 79 years
Sex
FEMALE
Healthy Volunteers
Yes
UPMC Magee-Womens Imaging - Bethel Park
Bethel Park, Pennsylvania, United States
UPMC Magee at the Lemieux Sports Complex
Cranberry Township, Pennsylvania, United States
Magee Womancare Monroeville
Monroeville, Pennsylvania, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center at Shadyside
Pittsburgh, Pennsylvania, United States
UPMC West Mifflin Outpatient Center
West Mifflin, Pennsylvania, United States
Start Date
November 8, 2023
Primary Completion Date
December 1, 2029
Completion Date
April 1, 2031
Last Updated
September 11, 2025
1,500
ESTIMATED participants
contrast-enhanced mammography
DEVICE
Lead Sponsor
Wendie Berg
Collaborators
NCT05673200
NCT04550494
Data Source & Attribution
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