The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts
Recruiting · NCT05667532 · Interventional (participants receive a specific treatment) · Lead sponsor: M.D. Anderson Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Contrast Enhanced Mammography
What this trial is about
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
Who can take part
Age range
30 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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)
Where it is running
1 location listed across 1 US state.
- M D Anderson Cancer Center - Houston, Texas, United States