Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer

NCT01303419 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2019-04-10

Study results available
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Summary

Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).

Conditions

Interventions

DEVICE

CE-BMRI

Contrast-enhanced breast imaging using Magnetic Resonance

DEVICE

DE-CEDM

Breast imaging using Dual-energy, contrast-enhanced digital mammography

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany

Study Locations

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Entities

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 NCT01303419 on ClinicalTrials.gov