Clinical Trial: NCT05206331
CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
Status:
COMPLETEDPhase:
Phase 4| Lead Sponsor: | Margarita Louise Zuley |
| Information Provided By: | University of Pittsburgh |
| Last Update Posted: | 2026-09-15 |
Study Overview
Brief Summary
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%.
Official Title
Conditions
Intervention / Treatment
- Device: contrast enhanced mammography
- Drug: Iodinated Contrast Media (ICM)
Other Study ID Numbers
- STUDY21070030
- 1R01CA258898
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Margarita Louise Zuley |
| Information Provided By: | University of Pittsburgh |
| Last Update Posted: | 2026-09-15 |
Study Overview
Brief Summary
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%.
Official Title
Conditions
Intervention / Treatment
- Device: contrast enhanced mammography
- Drug: Iodinated Contrast Media (ICM)
Other Study ID Numbers
- STUDY21070030
- 1R01CA258898