Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer
Enrolled women will undergo a bilateral 2-view DE-CEDM examination after administration of an iodinated contrast agent. Separate readers on-site will evaluate DE-CEDM+MX (standard mammography) and CE-BMRI+MX to determine the extent of disease. An integrated reading of both sets of images will be performed either by one or the two readers. DE-CEDM will not be used to change the diagnosis. Lesions that are confirmed as suspicious by MX, CE-BMRI, or follow-up breast ultrasound (US) will undergo biopsy. Truth about extent of disease will be based on histologic analysis of surgical specimens along with follow-up MX 10-15 months after the study exam. A randomized, blinded image evaluation will be done with 11 to 15 radiologist readers to compare DE-CEDM+MX and CE-BMRI+MX for assessment of disease extent.
|Study Design:||Intervention Model: Single Group Assignment
Masking: 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|
- DE-CEDM - CE-BMRI Comparison for the identification of women whose clinical management would be changed. [ Time Frame: 15 months ] [ Designated as safety issue: No ]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).
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Other: DE-CEDM and CE-BMRI
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States|
|AZ St-Jan Brugge AV|
|Sunnybrook Health Science Centre|
|Institut Goustave Roussy|
|Institut fur Radiologie, Charite|