Prostate Cancer Clinical Trial
Official title:
Prospective, Multi-Center Study of the ClariCore™ Optical Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy For Prostate Tissue Classification Algorithm Development
The purpose of the study is to collect information on prostate tissue biopsies collected with the ClariCore System during a radical prostatectomy procedure. The ClariCore System is designed to improve how biopsies are taken from the prostate by using light sensors (fiber optics) that can see changes in the tissue. The information collected from the study will be used to develop a method to tell the difference between normal and suspicious tissue to help guide the physician during a biopsy procedure.
The overall objective of this study is to acquire and analyze spectral data and correlative
tissue biopsy cores using the ClariCore System for the purpose of algorithm development.
The system algorithm will be trained to identify real-time in vivo 'Normal' versus
'Suspicious' prostate tissue. The 'Normal' or 'Suspicious' assignment will be based on the
optical signal principle component parameters of the measured signal when compared to a
threshold to be derived from pathologically known values of suspicious (or possibly
cancerous) and normal (or non-cancerous) measurements in prostate tissue.
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