NCT05667532

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Contrast Enhanced Mammography	Screening Modality

Timeline

• Start date: 2022-12-05
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2022-12-28
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States