Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures

用于引导核心针活检程序的智能光学探头

• 批准号: 10625956
• 负责人: NICUSOR IFTIMIA
• 金额: $ 89.01万
• 依托单位: PHYSICAL SCIENCES, INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-23 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10625956
• 关键词: Achievement; Address; Algorithmic Software; Animal Cancer Model; Animals; Area; Benign; Biopsy; Businesses; Cancer Center; Cells; Cellularity; Cicatrix; Clinical; Clinical Data; Clinical Paths; Collaborations; Confidence Intervals; Contracts; Core Biopsy; Data; Databases; Diagnosis; Emotional; Engineering; Evaluation; Family; Feedback; Genetic Materials; Goals; Government; Health Care Costs; Histologic; Histology; Histopathology; Human; Image; Image Analysis; In Situ; Institutional Review Boards; Intelligence; Intervention; Light; Liver; Lung; Malignant Neoplasms; Marketing; Measures; Morphology; Necrosis; Needle biopsy procedure; Needles; Optical Biopsy; Optical Coherence Tomography; Optics; Organ; Outcome; Pathology; Patients; Persons; Phase; Procedures; Research; Resolution; Resources; Safety; Secure; Sensitivity and Specificity; Small Business Innovation Research Grant; Solid; Solid Neoplasm; Sterilization; Techniques; Technology; Time; Tissue imaging; Tissues; Training; Translating; Tumor Tissue; United States National Institutes of Health; Validation; cancer diagnosis; commercialization; cost; design; diagnostic value; efficacy evaluation; high resolution imaging; human imaging; human study; improved; in vivo evaluation; instrument; instrumentation; lymph nodes; new technology; novel; optical imaging; physical science; programs; radiological imaging; radiologist; research clinical testing; success; tool; tumor; tumor heterogeneity; ultrasound

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.

项目摘要/摘要 物理科学公司（PSI）与MD Anderson癌症中心（MDACC）合作提议 开发和临床评估了一种新型探针，以指导核心针活检。该探针将揭示组织 实时活检针头的形态学，从而有助于介入放射科医生正确 选择肿瘤内的活检区域。这是需要的，因为肿瘤可能非常异构，包含 坏死细胞或疤痕组织，没有任何诊断值。该活检探针称为“ optoguide”，是 基于使用基于编码器的新型光学相干断层扫描（OCT）方法的使用，该方法可以在 使用非常简单的探针和负担得起的OCT仪器进行原位组织成像。我们已经成功证明了 在先前完成的SBIR合同计划中，该技术在癌症的动物模型中 （HHSN261201600030C）。但是，需要进一步的努力和其他资源来翻译这一点 常规临床用途的技术。因此，该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将开发一种临床上可行的仪器，对MDACC的人类患者进行评估，并开始 生成需要进行监管批准和营销目的所需的临床数据。