Using contrast-enhanced mammography to reduce unnecessary breast biopsies
Contrast Enhanced Mammography (CEM) to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
This study is testing if a special type of mammogram can help women avoid unnecessary breast biopsies while still finding any cancers that might be there.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2100 (estimated) |
| Ages | 30 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05206331 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of contrast-enhanced mammography (CEM) in reducing biopsy rates for women with breast abnormalities classified as BIRADS 4A or 4B. The study involves performing CEM on patients scheduled for biopsy to determine if it can lower the number of unnecessary biopsy recommendations while maintaining a high cancer detection rate. By comparing radiologists' assessments using traditional imaging methods and CEM, the trial aims to validate the hypothesis that CEM can significantly reduce the number of benign cases that require biopsy. The study will enroll 1855 women and assess the negative predictive value of CEM in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 30 and older with suspicious breast abnormalities scheduled for imaging-directed biopsies.
Not a fit: Patients who are pregnant, breastfeeding, or have a known allergy to iodinated contrast will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the number of unnecessary breast biopsies, alleviating patient anxiety and stress.
How similar studies have performed: Preliminary findings from earlier studies suggest that CEM may improve diagnostic accuracy compared to traditional imaging methods, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is female of any race and ethnicity * Subject is ≥30 years old * Subject is diagnosed with a suspicious breast abnormality and is scheduled for an imaging directed breast biopsy. Exclusion Criteria: * Subject is unable or unwilling to undergo informed consent * Subject has a breast implant in the breast of interest * Subject is pregnant * Subject is breast-feeding * Subject is actively being treated for cancer of any type with chemotherapy * Subject has reduced kidney function with eGFR \< 30. * Subject has had a prior reaction to iodinated contrast; thus a known allergy to iodinated contrast
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Margarita L Zuley, MD — University of Pittsburgh
- Study coordinator: Suzanne Burdin, BS
- Email: burdins@upmc.edu
- Phone: 412-647-7385
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.