Using contrast-enhanced mammography to predict breast cancer
Contrast-Enhanced Mammography (CEM) for the Evaluation and Targeted Biopsy of Suspicious Mammographic Architectural Distortions
This study is testing if a special type of mammogram that uses contrast dye can better predict breast cancer in women with suspicious breast scans compared to regular mammograms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 85 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04871139 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of contrast-enhanced mammography (CEM) in predicting breast cancer compared to standard mammography. CEM involves an intravenous injection of iodine-based contrast to enhance the visibility of tissues and blood vessels in breast scans. The study aims to assess the sensitivity and specificity of CEM in detecting invasive malignancy or ductal carcinoma in situ (DCIS) in patients with suspicious mammographic architectural distortions. Additionally, it will explore the correlation between CEM findings and the need for biopsies, as well as the potential role of blood biomarkers in cancer detection.
Who should consider this trial
Good fit: Ideal candidates are women aged 25-85 with suspicious mammographic architectural distortions who are recommended for a stereotactic biopsy.
Not a fit: Patients with a history of allergic reactions to iodinated contrast, renal insufficiency, or recent breast surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of breast cancer detection and lead to better-targeted biopsies.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for cancer detection, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with suspicious MADs recommended for a stereotactic biopsy who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their biopsy at MDACC * Age 25-85 years * Willing to participate in the study, undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent Exclusion Criteria: * Reported history of an allergic reaction to iodinated contrast * History of anaphylactic reaction to any substance * Renal insufficiency * Pregnancy or lactation within 6 months * Breast surgery affecting the site of interest within prior 6 months * Breast biopsy at the site of interest within the last 2 months
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Olena Weaver — M.D. Anderson Cancer Center
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.