Breast Cancer Clinical Trial
The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts
Summary
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
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Female patients 30-75 years of age with dense breasts (ACR BI-RADS categories C and D) who undergo routine yearly mammography at participating MDACC sites
Willingness to co-enroll or currently enrolled in PA17-0584
Willingness to participate in the study and ability to provide informed consent
Exclusion Criteria:
Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain.
Current or recent (within the prior 6 months) history of pregnancy or breast feeding
Personal history of breast cancer (DCIS or invasive breast cancer)
Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer
Breast biopsy within 6 months
Breast surgery within 12 months
Breast MRI, MBI, or CEM performed within 24 months
Known allergy to iodine-containing contrast agents
History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast
Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)
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There is 1 Location for this study
Houston Texas, 77030, United States More Info
Principal Investigator
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