Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures

项目概要/摘要 物理科学公司(PSI)，与MD安德森癌症中心（MDACC）合作， 开发并临床评估用于引导芯针活检的新型探针。这个探测器会发现 活检针尖端处的形态，从而帮助介入放射科医生正确地 选择肿瘤内的活检区域。这是必要的，因为肿瘤可以是非常异质性的， 坏死细胞或疤痕组织，没有任何诊断价值。这种活检探针被称为“OptoGuide”， 基于使用一种新的基于编码器的光学相干断层扫描（OCT）方法， 使用非常简单的探头和经济实惠的OCT仪器进行原位组织成像。我们成功地证明了 在先前完成的SBIR合同项目中， （HHSN261201600030C）。然而，需要进一步努力和额外资源来实现这一目标， 常规临床应用。因此，本第二阶段计划的主要目标是缩小以下方面的差距： 研究和商业化阶段，使技术过渡到临床使用。具体地说， PSI将开发一种临床可行的仪器，在MDACC对人类患者进行评估，并开始 生成监管批准和营销目的所需的临床数据。

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.