Breast Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTContrast Enhanced Mammography
Screening Modality
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify female MDACC patients with dense breasts who undergo contrast-enhanced mammography | through study completion; an average of 1 year. |
Countries
United States
Contacts
Primary ContactOlena Weaver, MD
Outcome results
None listed