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COMPLETED
NCT04764292
PHASE4

Screening Contrast-Enhanced Mammography as an Alternative to MRI

Sponsor: Wendie Berg

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

615

Start Date

2021-02-15

Completion Date

2025-05-30

Last Updated

2026-05-22

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Contrast-enhanced mammography

supplemental breast cancer screening with contrast-enhanced mammography

DRUG

Iodinated Contrast Media (ICM)

supplemental breast cancer screening with contrast-enhanced mammography

Locations (3)

UPMC Magee at the Lemieux Sports Complex

Cranberry Township, Pennsylvania, United States

UPMC Magee Monroeville Breast Care Center

Pittsburgh, Pennsylvania, United States

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States