Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures

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Project Summary/Abstract Physical Sciences, Inc. (PSI), in collaboration with MD Anderson Cancer Center (MDACC) proposes to develop and clinically evaluate a novel probe for guiding core needle biopsies. This probe will reveal tissue morphology at the tip of the biopsy needle in real-time and thus aid the interventional radiologist to properly select the biopsy area within the tumor. This is needed because tumors can be very heterogeneous, containing necrotic cells or scar tissue, which do not have any diagnostic value. This biopsy probe, called "OptoGuide", is based on the use of a novel encoder-based optical coherence tomography (OCT) approach, which enables in situ tissue imaging with a very simple probe and affordable OCT instrument. We have successfully demonstrated this technology in an animal model of cancer during a previously completed SBIR contract program (HHSN261201600030C). However, further efforts and additional resources are needed to translate this technology to routine clinical use. Thus, the primary goal of this Phase II program is to close the gap between the research and the commercialization phases, enabling technology transition towards clinical use. Specifically, PSI will develop a clinically viable instrument, perform its evaluation on human patients at MDACC, and start generating clinical data needed for regulatory approval and marketing purposes.