NCT05206331 · ClinicalTrials.gov record · last posted 2025-10-08
CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
StatusRecruiting
PhasePhase 4
Started2022-02-01
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
One of the primary criticisms of mammography is that it leads to unneeded stress and anxiety from identification and biopsy of non-cancerous findings. Contrast-enhanced mammography (CEM) has the potential to significantly reduce biopsy rates for commonly seen benign breast lesions while preserving very high cancer detection. The investigators propose a prospective clinical study of patients with diagnostic mammograms rated as BIRADS 4A or 4B and scheduled for a biopsy, in which, prior to undergoing their scheduled biopsy, a CEM procedure is performed. The investigators will test the primary hypothesis that for soft tissue lesions (i.e. masses, asymmetries, architectural distortions) initially rated BI-RADS 4A/4B adding CEM will reduce, by at least 20%, the number of biopsy recommendations for actually benign cases and, at the same time, provide a negative predictive value (NPV) higher than 95%.
Amendment record
7 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 7 times since 2022-01-24; most recent amendment 2025-10-03. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
See every version on ClinicalTrials.gov ↗
2022-02-01
Status change Not Yet Recruiting→Recruitingv1
| NCT Number |
NCT05206331 |
| Lead Sponsor |
Margarita Louise Zuley
Collaborators: National Cancer Institute (NCI) |
| Conditions |
Breast Cancer |
| Enrollment |
2,100 participants |
| Start Date |
2022-02-01 |
| Primary Completion |
2026-11-30 (estimated) |
| Study Completion |
2027-11-30 (estimated) |
| Updated on ClinicalTrials.gov |
2025-10-08 |