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.

抽象的 癌症患者手术治疗的主要目标是清除所有癌细胞 从体内进行，次要目标是维持器官功能。原发性病理 用于评价手术成功与否的指标是评估切除的手术边缘 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 探索这些组织样本边缘是否存在癌细胞。注意到癌细胞 切缘代表手术切缘阳性 (PSM)，表明癌细胞留在体内 遵循程序。因此，PSM 患者经常需要接受有害的额外手术 根除留下的癌细胞，包括放射、化学、激素和其他手术治疗； 这些都具有降低患者生活质量的不良发病率。没有常规的临床方案 用于在手术过程中术中评估手术切缘状态。相反，边距是 当为时已晚时，通过手术后组织的显微镜评估进行评估 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设备 状态，以便外科医生可以实时提取额外的组织，并最终降低发生率 PSM。虽然我们的技术可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，因为这是男性发病率最高和死亡的原因，而且患有 PSM 的患者 与接受阴性手术的患者相比，接受这些手术的患者的复发率要高得多 边距。我们之前已经证明了电阻抗（描述电阻抗的容易程度的属性） 电流通过组织）组织对组织的细胞排列敏感，并且可以 用于区分前列腺中的癌症和良性组织。我们开发了一种柔性内窥镜原型 能够在根治性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。该设备对边缘状态进行焦点测量。 在这里，我们的目标是迈出构建可部署的优化 EIT 设备的重要一步 腹腔镜检查（例如前列腺手术）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来帮助指导 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 在这个计划中，我们打算开发一种低成本、一次性的探针，可以部署在多用途环境中。 中心临床试验旨在评估该技术用于术中手术切缘评估的功效。