Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women with Dense Breasts, The C-MERIT Screening Cohort

PRIMARY OBJECTIVES:

I. To establish a cohort of 1,000 female MD Anderson Cancer Center (MDACC) patients with dense breasts who undergo screening contrast-enhanced mammography.

II. 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:

I. To perform within-subject comparison of the cancer detection rate between CEM and full-field digital mammogram (2D mammogram) (FFDM).

II. 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 digital breast tomosynthesis (3D mammogram) (DBT) images among women with dense breasts.

III. To evaluate the effect of the availability of prior imaging for comparison on the recall rates of CEM, FFDM and DBT.

IV. 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:

I. To combine imaging, blood biomarkers, health measurements and questionnaire data for assessment of breast cancer risk.

II. To evaluate if the intensity of background parenchymal enhancement on CEM predicts breast cancer risk in women with dense breasts.

III. To evaluate if patients consider CEM as a potentially acceptable imaging modality for routine breast cancer screening.

OUTLINE:

Patients undergo CEM imaging at the time of their regular yearly mammography. Patients who are not diagnosed with breast cancer at initial visit, undergo additional CEM imaging 10 to 22 months later. Patients also undergo blood sample collection.

After completion of study intervention, patients are followed up to 24 months.