The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Contrast Enhanced Mammography
|
Diagnostic Test: Contrast Enhanced Mammography
Screening Modality
|
Outcome Measures
Primary Outcome Measures
- To identify female MDACC patients with dense breasts who undergo contrast-enhanced mammography [through study completion; an average of 1 year.]
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Olena Weaver, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2022-0651
- NCI-2022-10200