Early detection of breast cancer improves the survival rate and makes treatment less costly. This study would measure the accuracy a low-cost hand-held commercially viable device, iBE, for the detection of clinically relevant findings in the breast using the results of current mammography as a comparison. This research will have no impact on clinical decision making.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Enrollment
89
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Number of Quadrants With Detected Breast Lesions
The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12).
Time frame: 3 months
Sensitivity of iBE Breast Lesion Detection
the number of quadrants with positive breast lesion detected by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant. 77 quadrants were labeled positive for breast lesion by iBE, 66 were confirmed positive by mammogram or ultrasound allowing calculation of sensitivity of the the iBE breast lesion detection
Time frame: 1 day
Specificity of iBE Breast Lesion Detection
the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant
Time frame: 1 day
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