Using Contrast-Enhanced Mammography to Improve Breast Cancer Screening in Women with Dense Breasts
The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts
This study is testing if a special type of mammogram called Contrast-Enhanced Mammography can find breast cancer better than regular mammograms in women with dense breasts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05667532 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of Contrast-Enhanced Mammography (CEM) compared to standard mammography in detecting breast cancer among women with dense breasts. It will establish a cohort of 1,000 female patients who will undergo CEM and collect comprehensive data, including imaging and health measurements. The study will also compare cancer detection rates, sensitivity, specificity, and recall rates between CEM and other imaging modalities. Additionally, it will explore the relationship between imaging results and breast cancer risk factors.
Who should consider this trial
Good fit: Ideal candidates are women aged 30-75 with dense breasts who are undergoing routine yearly mammography.
Not a fit: Patients with a personal history of breast cancer or recent breast symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved breast cancer detection rates in women with dense breasts, potentially saving lives through earlier diagnosis.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for breast cancer detection, suggesting that this approach could be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Olena Weaver, MD — M.D. Anderson Cancer Center
- Study coordinator: Olena Weaver, MD
- Email: ooweaver@mdanderson.org
- Phone: (713) 745-4555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.