CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 615 enrolled
Drug / intervention
Iodinated Contrast Media (ICM) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04764292
NCT04764292Phase 4Completed

Screening Contrast-Enhanced Mammography as an Alternative to MRI

Wendie Berg·interventional·Posted Feb 21, 2021·Updated May 22, 2026

In Brief

A Phase 4 clinical trial evaluating Contrast-enhanced mammography and Iodinated Contrast Media (ICM) for Breast Cancer. Completed, enrolled 615 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedFeb 21, 2021
Enrollment StartFeb 15, 2021
Primary CompletionMay 30, 2025
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 5.4 years ago

Interventions

Contrast-enhanced mammographydevice

supplemental breast cancer screening with contrast-enhanced mammography

Iodinated Contrast Media (ICM)drug

supplemental breast cancer screening with contrast-enhanced mammography