Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01303419|
Recruitment Status : Terminated (Sponsor determined there was sufficient material collected to answer the study questions.)
First Posted : February 24, 2011
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: CE-BMRI Device: DE-CEDM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||June 30, 2012|
|Actual Study Completion Date :||June 30, 2012|
Active Comparator: CE-BMRI
Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis.
Contrast-enhanced breast imaging using Magnetic Resonance
Subject will undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.
Breast imaging using Dual-energy, contrast-enhanced digital mammography
- DE-CEDM - CE-BMRI Comparison for the identification of women whose clinical management would be changed. [ Time Frame: 15 months ]DE-CEDM - CE-BMRI Comparison for the identification of women whose clinical management would be changed (defined as: presence of additional foci in the contralateral breast, and/or presence of additional foci at least 2 cm from the primary cancer in the ipsilateral breast, and/or change in size of the primary by at least 2 cm).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303419
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|
|AZ St-Jan Brugge AV|
|Sunnybrook Health Science Centre|
|Institut Goustave Roussy|
|Institut fur Radiologie, Charite|