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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 RecruitingRecruitingv1
Trial Details
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