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: 10218115
• 负责人: Ryan Joseph Halter
• 金额: $ 47.81万
• 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/10218115
• 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; Machine Learning; 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; 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 手术治疗癌症患者的主要目的是去除所有癌细胞 从身体内部，以维持器官功能为次要目标。主要病理 用于评定外科手术成功率的度量是对切除的肿瘤的手术边缘的评估。 组织标本，术后。这通常涉及将组织切成切片，并在显微镜下观察 探索这些组织样本的边缘是否存在癌细胞。癌细胞在 边缘代表阳性手术边缘（PSM），表明癌细胞留在体内 遵循程序。因此，PSM患者经常暴露于有害的额外手术， 根除遗留的癌细胞，包括放射，化学，激素和额外的手术治疗; 这些都具有降低患者生活质量的不良发病率。没有临床协议是常规的 用于在手术过程中评估手术切缘状态。相反，利润率 在手术后通过组织的显微镜评估进行评价，当提供时为时已晚 额外的手术干预。我们的目标是开发一种能够评估手术切缘的术中装置 状态，以便外科医生可以实时提取额外的组织，并最终降低 PSM。虽然我们的技术可以应用于大多数癌症手术，但我们将重点放在前列腺手术上。 癌症，因为这些是男性的最高发病率和死亡原因， 这些手术后的复发率比手术阴性的患者高得多。 利润率我们之前已经表明，电阻抗（一种描述如何容易地 电流通过组织）对组织的细胞排列敏感， 用于区分前列腺中的癌症和良性组织。我们已经开发出一种原型柔性内窥镜 能够在根治性直肠癌切除术过程中对电阻抗组织成像的装置， 电阻抗断层扫描（EIT）技术。该设备对边缘状态进行焦点测量。 在这里，我们的目标是采取重要的一步，构建一个优化的EIT设备，可以部署 腹腔镜检查（例如前列腺手术），以提供术中识别阳性的准确方法 手术切缘我们的目标是开发这种设备，开发术中可视化策略，以帮助引导 外科医生，在体内研究中评估该技术，并在术中验证该技术。年底 在这个项目中，我们打算开发一种低成本、一次性使用的探头， 中心临床试验，以评估该技术用于术中手术切缘评估的有效性。