Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures

项目摘要/摘要 物理科学公司(PSI)与MD安德森癌症中心(MDACC)合作提出 研制一种用于引导芯针活检的新型探头并进行临床评价。这个探测器将揭示组织 实时观察活组织检查针尖的形态，从而帮助介入放射科医生 选择肿瘤内的活检区域。这是必要的，因为肿瘤可能是非常不同的，包含 坏死细胞或疤痕组织，这对诊断没有任何价值。这种活组织检查探头名为“OptoGuide”， 基于一种新的基于编码器的光学相干层析(OCT)方法的使用，该方法能够在 使用非常简单的探头和负担得起的OCT仪器进行原位组织成像。我们已经成功地展示了 这项技术在之前完成的SBIR合同计划期间的癌症动物模型中 (HHSN261201600030C)。然而，需要进一步的努力和额外的资源来翻译这一点 技术应用于常规临床。因此，这一第二阶段计划的主要目标是缩小 研究和商业化阶段，使技术过渡到临床使用。具体来说， PSI将开发一种临床可行的工具，在MDACC对人类患者进行评估，并开始 生成监管审批和营销所需的临床数据。

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.