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

NCT ID: NCT05667532

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2028-12-31

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Contrast Enhanced Mammography

Group Type: EXPERIMENTAL

Contrast Enhanced Mammography

Intervention Type: DIAGNOSTIC_TEST

Screening Modality

Interventions

Contrast Enhanced Mammography

Screening Modality

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olena Weaver, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Olena Weaver, MD

Role: CONTACT

ooweaver@mdanderson.org

(713) 745-4555

Facility Contacts

Olena Weaver, MD

Role: primary

ooweaver@mdanderson.org

713-745-4555

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2022-10200

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0651

Identifier Type: -

Identifier Source: org_study_id