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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要物理科学公司 (PSI) 与 MD 安德森癌症中心 (MDACC) 合作提议开发并临床评估一种用于引导空心针活检的新型探针。该探针将揭示组织实时了解活检针尖端的形态，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，因为肿瘤可能非常异质，包含坏死细胞或疤痕组织，没有任何诊断价值。这种活检探针称为“OptoGuide”，基于使用一种新颖的基于编码器的光学相干断层扫描（OCT）方法，该方法能够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。我们已经成功展示了在之前完成的 SBIR 合同项目中，这项技术在癌症动物模型中得到应用 (HHSN261201600030C)。然而，需要进一步的努力和额外的资源来转化这一点技术常规临床使用。因此，第二阶段计划的主要目标是缩小之间的差距研究和商业化阶段，使技术能够过渡到临床使用。具体来说， PSI 将开发一种临床上可行的仪器，在 MDACC 对人类患者进行评估，并开始生成监管审批和营销目的所需的临床数据。