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To learn whether a new imaging technology, Contrast-Enhanced Mammography (CEM), compared to standard mammography, can better detect breast cancers in women with dense breasts
Primary Objectives: * To establish a cohort of 1,000 female MDACC patients with dense breasts who undergo screening contrast-enhanced mammography. * To establish a comprehensive integrated database of imaging, clinical data, health measurements, and questionnaire data including data from the companion protocol PA17-0584. Secondary Objectives: * To perform within-subject comparison of the cancer detection rate between CEM and FFDM. * To perform within-subject comparison of the sensitivity, specificity, and recall rates of CEM compared to low-energy (LE) images (FFDM equivalent) and compared to a combination of LE and DBT images among women with dense breasts. * To evaluate the effect of the availability of prior imaging for comparison on the recall rates of CEM, FFDM and DBT. * In patients who undergo screening breast ultrasound as a standard of care, to evaluate the performance of screening ultrasound for breast cancer detection and compare it with other imaging modalities of CEM, LE images, and DBT. Exploratory Objectives: * To combine imaging, blood biomarkers, health measurements and questionnaire data for assessment of breast cancer risk. * To evaluate if the intensity of background parenchymal enhancement on CEM predicts breast cancer risk in women with dense breasts. * To evaluate if patients consider CEM as a potentially acceptable imaging modality for routine breast cancer screening.
Age
30 - 75 years
Sex
FEMALE
Healthy Volunteers
No
M D Anderson Cancer Center
Houston, Texas, United States
Start Date
December 5, 2022
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2028
Last Updated
January 9, 2026
1,000
ESTIMATED participants
Contrast Enhanced Mammography
DIAGNOSTIC_TEST
Lead Sponsor
M.D. Anderson Cancer Center
NCT05673200
NCT04704661
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