The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts
2 other identifiers
interventional
1,000
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Dec 2022
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2022
CompletedStudy Start
First participant enrolled
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
January 9, 2026
January 1, 2026
4.1 years
November 30, 2022
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To identify female MDACC patients with dense breasts who undergo contrast-enhanced mammography
through study completion; an average of 1 year.
Study Arms (1)
Contrast Enhanced Mammography
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
- Willingness to co-enroll or currently enrolled in PA17-0584
- Willingness to participate in the study and ability to provide informed consent
You may not qualify if:
- Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain.
- Current or recent (within the prior 6 months) history of pregnancy or breast feeding
- Personal history of breast cancer (DCIS or invasive breast cancer)
- Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer
- Breast biopsy within 6 months
- Breast surgery within 12 months
- Breast MRI, MBI, or CEM performed within 24 months
- Known allergy to iodine-containing contrast agents
- 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
- Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olena Weaver, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2022
First Posted
December 28, 2022
Study Start
December 5, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
January 9, 2026
Record last verified: 2026-01