The primary aim of this study is to show that the accuracy of Koning Breast CT-guided biopsy is at least equivalent to that of stereotactic-guided biopsy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
4
The breast will be positioned and stabilized in the grid/compression device. Four KBCT scans will be taken to guide the vacuum-assisted biopsy procedure.
Elizabeth Wende Breast Care
Rochester, New York, United States
The accuracy of Koning breast CT-guided biopsy
The goal of this study is to evaluate the concordance of Koning Breast CT-guided Biopsy (KBCT-GBx) results to diagnostic work-up imaging (at least mammographic) and KBCT imaging and to verify that the localization and guidance accuracy of KBCT-GBx is at least equivalent to stereotactic-guided biopsy to validate the localization and guidance accuracy of KBCT-GBx.
Time frame: about 1 year
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