Using contrast-enhanced mammography to evaluate suspicious breast microcalcifications
Contrast-Enhanced Mammography (CEM) and CEM-Directed Biopsy for the Evaluation of Extensive Suspicious Mammographic Microcalcifications
This study is testing if a new type of mammogram called contrast-enhanced mammography can better identify serious breast cancer in women who have suspicious microcalcifications on their regular mammograms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 151 (estimated) |
| Ages | 25 Years to 85 Years |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05046301 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of contrast-enhanced mammography (CEM) in predicting the presence of high-grade ductal carcinoma in situ (DCIS) or invasive cancer in women with suspicious mammographic microcalcifications. The study compares the sensitivity and specificity of CEM to traditional two-dimensional mammography, aiming to improve diagnostic accuracy and reduce false positives. Additionally, it explores the correlation between imaging findings and blood biomarkers, as well as the technical feasibility of CEM-guided procedures. The trial is conducted at the M.D. Anderson Cancer Center, focusing on women who are recommended for a stereotactic biopsy.
Who should consider this trial
Good fit: Ideal candidates are women aged 25-85 with suspicious mammographic microcalcifications categorized as BI-RADS 4 or 5, who are recommended for a stereotactic biopsy.
Not a fit: Patients with a history of allergic reactions to iodinated contrast or renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate breast cancer diagnoses and reduce unnecessary biopsies for patients.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques like CEM for breast cancer detection, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with suspicious mammographic microcalcifications (Breast Imaging Reporting and Data System \[BI-RADS\] categories 4 or 5) occupying an area equal to or exceeding 4 cm in diameter and 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 stereotactic biopsy at MDACC. * Age 25-85 years * Willing to participate in the study, undergo an intravenous (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 that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast * 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 * Mammographic mass or architectural distortion associated with the calcifications in question
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
- Study coordinator: Ada Lo
- Email: alo@mdanderson.org
- Phone: 713-794-4404
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.