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
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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