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Study of Contrast-Enhanced Mammography (CEM) to Reduce Breast Biopsies

This study is looking at whether a special type of mammogram, called contrast-enhanced mammography (CEM), can help reduce the number of unnecessary breast biopsies. CEM uses a special dye called Iodinated Contrast Media (ICM) and a modified mammogram device to get more detailed images. The goal is to see if CEM can help doctors better tell the difference between suspicious but non-cancerous breast findings and actual breast cancer, which could mean fewer people need to have a biopsy. You might be able to join if you are a woman at least 30 years old, have a suspicious breast abnormality, and are already scheduled for a breast biopsy. The study will measure how well CEM can correctly identify non-cancerous findings over five years. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 2100 women. It will compare standard imaging with CEM to see if CEM improves biopsy recommendations.
What's involved
You would undergo a CEM procedure before your scheduled breast biopsy. The study will involve radiologists reviewing images from different methods.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed for five years to see how well CEM predicted negative outcomes.

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NCT05206331

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

Recruiting
PHASE4Ages 30+InterventionalDiagnostic
Margarita Louise Zuley
~2,100 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:contrast enhanced mammographyIodinated Contrast Media (ICM)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Negative Predictive Value (NPV)
Measured over year 5

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Margarita L Zuley, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Suzanne Burdin, BS
[email protected]
412-647-7385
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Negative Predictive Value (NPV)year 5

    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).