NCT05206331 CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
| NCT ID | NCT05206331 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Margarita Louise Zuley |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,100 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,100 participants in total. It began in 2022-02-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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%.
Eligibility 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
Contact & Investigator
Margarita L Zuley, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05206331 clinical trial?
This trial is open to female participants only, aged 30 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05206331 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05206331 currently recruiting?
Yes, NCT05206331 is actively recruiting participants. Contact the research team at burdins@upmc.edu for enrollment information.
Where is the NCT05206331 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05206331 clinical trial?
NCT05206331 is sponsored by Margarita Louise Zuley. The principal investigator is Margarita L Zuley, MD at University of Pittsburgh. The trial plans to enroll 2,100 participants.
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