CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study

NCT05206331 | Recruiting Phase 4 FDA Drug FDA Device

• 2 other identifiers: STUDY210700301R01CA258898
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 1

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%.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Negative Predictive Value (NPV)

  The investigators will estimate and compare the changes in NPV of pre- and post CEM-based recommendations (where NPV is the proportion of pathology verified benign lesions out of post-CEM-downgraded to BIRADS 3 or lower).

  year 5

Secondary Outcomes (1)

• Positive Predictive Value of biopsies performed (PPV3)

  year 5

Other Outcomes (2)

• Frequencies

  year 5

• Positive predictive value of biopsy recommendations (PPV2)

  year 5

Study Arms (1)

contrast enhanced mammography

EXPERIMENTAL

Women who have been recently diagnosed with a suspicious abnormality for which they have scheduled a breast biopsy and meet inclusion criteria will be invited to have a contrast enhanced mammography before their scheduled biopsy procedure.

Device: contrast enhanced mammography; Drug: Iodinated Contrast Media (ICM)

Interventions

contrast enhanced mammography DEVICE

Dual-energy contrast images; low-energy CEM images will be obtained with a kilovoltage below 35 kVp while the high-energy images will be obtained with 45-49 kVp.The average glandular dose of the CEM procedure is approximately 2.44 mGy per view

contrast enhanced mammography

Iodinated Contrast Media (ICM) DRUG

standard FDA-approved low osmolarity Iodine contrast agent with 350-370 mg/ml

contrast enhanced mammography

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Margarita Louise Zuley: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Margarita L Zuley, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Burdin, BS

CONTACT

412-647-7385; burdins@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: eligible participants will have contrast enhanced mammography before their scheduled biopsy

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 25, 2022
• Study Start: February 1, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: after publication for indefinitely
• Access Criteria: secondary investigators for image analysis. Sharing via Box

Locations

US (1)