NCT01303419

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

A Multicenter, Open-Label, Crossover Trial to Assess Non-Inferiority of Dual Energy Contrast-Enhanced Digital Mammography (DE-CEDM) Compared to Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) for Identifying a Change in Patient Management in Women With Newly Diagnosed Breast Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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). Maximum lesion size was compared between the two imaging types. Subject data from both scans was planned to be included in a multi-reader evaluation; however, due to premature stop of the study, multi-reader data was not collected.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	CE-BMRI	Contrast-enhanced breast imaging using Magnetic Resonance
DEVICE	DE-CEDM	Breast imaging using Dual-energy, contrast-enhanced digital mammography

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-06-30
• Completion: 2012-06-30
• First posted: 2011-02-24
• Last updated: 2019-04-10
• Results posted: 2019-04-10

Locations

5 sites across 5 countries: United States, Belgium, Canada, France, Germany