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

Breast Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT05667532
• Study type: Observational
• Source: M.D. Anderson Cancer Center
• Contact: Olena Weaver, MD
• Phone: (713) 745-4555
• Email: ooweaver@mdanderson.org
• Status: Recruiting
• Start date: December 5, 2022
• Completion date: December 31, 2027