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

• 批准号: 10433913
• 负责人: Ryan Joseph Halter
• 金额: $ 49.02万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 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/10433913
• 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; Left; Location; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of prostate; 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; Quality of life; Radiation; Radical Prostatectomy; Recurrence; 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; Visualization; Visualization software; Work; base; 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 probe; improved; in vivo; machine learning classification; man; men; mortality; neurovascular; programs; prostate surgery; prototype; safety and feasibility; stem; success; tool; tumor; urinary bladder neck

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.

摘要