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NCT05667532 | RECRUITING | Breast Cancer

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

M.D. Anderson Cancer Center

Brief 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

Condition or disease

Breast Cancer

Intervention/treatment

Contrast Enhanced Mammography

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 1000 participants
Official Title : The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts
Actual Study Start Date : 2022-12-05
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 75 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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)
The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts

Location Details

NCT05667532

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Locations

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030