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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：
10481578
负责人：
NICUSOR IFTIMIA
金额：
$ 88.87万
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 2024-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10481578
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 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 Reading 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 base cancer diagnosis commercialization cost design diagnostic value 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.

项目总结/文摘