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

Sponsored by M.D. Anderson Cancer Center

About this study

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 patien…

Where this study is enrolling

Who can participate

Inclusion criteria

  • ✓1. 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
  • ✓2. Willingness to co-enroll or currently enrolled in PA17-0584
  • ✓3. Willingness to participate in the study and ability to provide informed consent

Exclusion criteria

  • ✕1. Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain.
  • ✕2. Current or recent (within the prior 6 months) history of pregnancy or breast feeding
  • ✕3. Personal history of breast cancer (DCIS or invasive breast cancer)
  • ✕4. Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer
  • ✕5. Breast biopsy within 6 months
  • ✕6. Breast surgery within 12 months
  • ✕7. Breast MRI, MBI, or CEM performed within 24 months
  • ✕8. Known allergy to iodine-containing contrast agents
  • ✕9. 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
  • ✕10. Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

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Trial data sourced from ClinicalTrials.gov.