Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment

用于实时术中手术边缘评估的显微内窥镜电阻抗传感

基本信息

批准号：
10654771
负责人：
Ryan Joseph Halter
金额：
$ 48万
依托单位：
DARTMOUTH COLLEGE
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-15 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10654771
关键词：
Adjuvant Therapy Benign Biochemical Bladder Control Breast Cancerous Cause of Death Chemicals Classification Clinic Clinical Clinical Protocols Clinical Research Databases Detection Devices Disease Electronics Elements Erectile dysfunction Evaluation Excision Exposure to Financial Hardship Frequencies Health Personnel Histopathology Hormonal Human Image Imaging technology Incidence Incontinence Institution Left Location Malignant - descriptor Malignant Neoplasms Malignant neoplasm of prostate Maps Measurement Methods Microscopic Morbidity - disease rate Multi-Institutional Clinical Trial Nephrectomy Operative Surgical Procedures Organ Outcome Pathologic Pathology Patients Pelvic floor structure Periprostatic Positioning Attribute Postoperative Period Procedures Property Prostate Prostatic Tissue Quality of life Radiation Radical Prostatectomy Recurrence Recurrent Malignant Neoplasm Regional Cancer Research Design Resected Risk Running Salvage Therapy Scheme Sensitivity and Specificity Series Specimen Surgeon Surgical margins System Techniques Technology Time Tissue Sample Tissues Translating Update Urethra Urinary Retention Visualization Visualization software Work cancer cell cancer recurrence cancer surgery cancer type clinically relevant cost cost effective data acquisition design efficacy evaluation electric impedance electrical impedance tomography electrical property expectation feasibility trial flexibility imaging capabilities imaging probe improved in vivo machine learning classification man men mortality neurovascular programs prostate surgery prototype safety and feasibility stem success technology validation tool tumor urinary bladder neck

项目摘要

ABSTRACT The primary objective of surgical therapy for the treatment of patients with cancer is to remove all cancer cells from within the body, with the secondary objective of maintaining organ function. The primary pathological metric used to rate the success of a surgical procedure is evaluation of the surgical margin of the resected tissue specimen, post-operatively. This typically involves cutting the tissue into sections and microscopically exploring these tissue samples for the presence of cancer cells at the margins. Cancer cells noted at the margins represent Positive Surgical Margins (PSMs) and suggest that cancer cells were left in the body following the procedure. As a result, patients with PSMs are often exposed to noxious additional procedures to eradicate the cancer cells left behind including radiation, chemical, hormonal, and additional surgical therapy; these all have adverse morbidities that decrease a patient's quality of life. No clinical protocols are routinely used to intraoperatively assess surgical margin status during surgical procedures. Instead, margins are evaluated through microscopic assessment of the tissue following the procedure, when it is too late to provide additional surgical intervention. We aim to develop an intraoperative device able to assess surgical margin status so that the surgeons can extract additional tissues in real-time and ultimately decrease the rates of PSMs. While our technology can be applied for most cancer surgeries, we are focusing our efforts on prostate cancer as these are the highest incidence and cause of death for men and because patients with PSMs following these procedures have a much higher rate of recurrence than patients that have negative surgical margins. We have previously shown that the electrical impedance (a property that describes how easily electrical current passes through a tissue) of tissue is sensitive to a tissue's cellular arrangement and can be used to distinguish cancer from benign tissue in prostate. We have developed a prototype flexible endoscopic device capable of imaging the electrical impedance tissue during radical prostatectomy procedures using Electrical Impedance Tomography (EIT) techniques. This device makes focal measurements of margin status. Here we aim to take the significant step of constructing an optimized EIT device that can be deployed laparoscopically (e.g. prostate surgery) to provide an accurate method of intraoperatively identifying positive surgical margins. We aim to develop this device, develop intraoperative visualization strategies to help guide surgeons, evaluate the technology in an in vivo study, and validate the technology intraoperatively. By the end of this program we intend to have developed a low-cost, single use probe that can be deployed in a multi- center clinical trial to evaluate the efficacy of this technology for intraoperative surgical margin assessment.

抽象的手术治疗治疗癌症患者的主要目标是去除所有癌细胞从体内，具有维持器官功能的次要目标。主要病理用于评估手术程序成功的度量是评估切除的手术缘组织标本，术后。这通常涉及将组织切成部分和显微镜探索这些组织样品以在边缘存在癌细胞。癌细胞在边缘代表阳性手术边缘（PSM），并表明癌细胞留在体内遵循程序。结果，PSM的患者通常会接受有害的其他程序消除留下的癌细胞，包括辐射，化学，荷尔蒙和其他手术疗法；这些都有不良病毒，可降低患者的生活质量。通常没有临床方案用于在手术程序中术中评估手术边缘状态。相反，利润是通过在程序之后对组织的微观评估进行评估，为时已晚其他手术干预。我们旨在开发能够评估手术边缘的术中装置状态，以便外科医生可以实时提取其他组织，并最终降低 PSM。虽然我们的技术可以用于大多数癌症手术，但我们将精力集中在前列腺上癌症是男性的最高发病率和死亡原因，因为PSMS患者遵循这些手术的复发率要比手术阴性的患者高得多利润。我们以前已经表明，电阻抗（一种描述了如何容易的特性电流通过组织的组织）对组织的细胞排列敏感，可以是用于区分前列腺中良性组织的癌症。我们已经开发了一个原型柔性内窥镜检查能够在从根治性的前列腺切除术过程中对电阻抗组织进行成像的装置电阻抗断层扫描（EIT）技术。该设备可进行边缘状态的焦点测量。在这里，我们旨在采取重大步骤来构建可以部署的优化EIT设备腹腔镜（例如前列腺手术）提供准确的术中鉴定阳性的方法手术边缘。我们旨在开发此设备，制定术中可视化策略以帮助指导外科医生在体内研究中评估该技术，并在术中验证该技术。到最后在该程序中，我们打算开发一种低成本的单使用探针，可以部署在多个中心临床试验评估该技术对术中手术边缘评估的功效。