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Screening Contrast-Enhanced Mammography as an Alternative to MRI

NCT04764292 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 615

Last updated 2026-05-22

Study results available
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Summary

There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, other constraints). Contrast-enhanced mammography (CEM) is a potential alternative to MRI for screening that uses updated standard mammography equipment to obtain low- and high-energy images after intravenous injection of iodinated contrast (as used in CT scanning). The investigators seek to validate screening CEM as an alternative to screening MRI.

Conditions

Interventions

DRUG

Iodinated Contrast Media (ICM)

supplemental breast cancer screening with contrast-enhanced mammography

DEVICE

Contrast-enhanced mammography

supplemental breast cancer screening with contrast-enhanced mammography

Sponsors & Collaborators

  • PA Breast Cancer Coalition

    collaborator UNKNOWN

  • Wendie Berg

    lead OTHER

Principal Investigators

  • Wendie Berg, MD, PhD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2025-05-30
Completion
2025-05-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04764292 on ClinicalTrials.gov