Contrast-Enhanced Mammography to Reduce Unnecessary Breast Biopsies for Low-to-Moderate Suspicion Findings
Contrast Enhanced Mammography (CEM) to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
['FUNDING_R01'] · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · NIH-11241077
This project uses contrast-enhanced mammography to help doctors decide whether women with low-to-moderate suspicious breast findings need a biopsy.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | UNIVERSITY OF PITTSBURGH AT PITTSBURGH (nih funded) |
| Locations | 1 site (PITTSBURGH, UNITED STATES) |
| Trial ID | NIH-11241077 on ClinicalTrials.gov |
What this research studies
If I have a mammogram showing a low- or moderate-suspicion spot (BI-RADS 4A or 4B), this project would add a contrast-enhanced mammogram during my diagnostic visit to see whether the spot lights up with contrast. Doctors will compare the contrast images to the usual mammogram, tomosynthesis, and ultrasound findings to refine their recommendation about biopsy. The goal is to avoid biopsies when the contrast image suggests a lesion is likely benign while still identifying cancers that need further workup. The testing is done prospectively during the patient's normal diagnostic evaluation so results could affect the same-day plan of care.
Who could benefit from this research
Good fit: Ideal candidates are women recalled for diagnostic workup whose imaging results are rated BI-RADS 4A or 4B and who can receive intravenous contrast.
Not a fit: Women with highly suspicious findings (BI-RADS 5), those already diagnosed with cancer, or those who cannot receive contrast (for example, severe kidney disease or contrast allergy) are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could cut down on unnecessary breast biopsies, reduce anxiety, and lower costs for many women.
How similar studies have performed: Earlier studies of contrast-enhanced mammography have shown promise in better highlighting cancers and reducing unnecessary biopsies, but large prospective trials focused on BI-RADS 4A/4B lesions are still limited.
Where this research is happening
PITTSBURGH, UNITED STATES
- UNIVERSITY OF PITTSBURGH AT PITTSBURGH — PITTSBURGH, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: ZULEY, MARGARITA L — UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- Study coordinator: ZULEY, MARGARITA L
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions: Breast Cancer Detection, Breast cancer screening