104
Participants
Start Date
June 30, 2008
Primary Completion Date
January 31, 2010
Study Completion Date
May 31, 2012
Computed Tomography
In Group I, twelve CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.
Computed Tomography
In Group II , at least fifty (50) study participants, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a breast CBCT specifically designed to image the breast.
Computed Tomography
In Group III, at least 30 study subjects, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a unilateral intravenous (IV) CE CBCT of the involved breast.
Elizabeth Wende Breast Care, Rochester
Lead Sponsor
Koning Corporation
INDUSTRY