Intraoperative Surgical Margin Assessment with Electrical Impedance Spectroscopy

描述(由申请人提供)：在前列腺手术中，没有常规的临床方案用于评估手术切缘状况。取而代之的是，通过根治性前列腺切除术(RP)后的前列腺病理评估来评估切缘，此时提供额外的手术干预已为时已晚。手术切缘阳性(PSM)是疾病复发的指征，并提示有害的辅助或抢救治疗。每年有10,000至40,000名男性被诊断为前列腺癌复发，原因是放射治疗后癌细胞残留。显然，能够评估手术切缘状态的术中装置有可能对患者的护理产生直接影响。在良性和恶性前列腺组织中观察到了显著不同的电特性特征，我们假设，术中测量这些特性有可能提供有关手术切缘病理的临床相关信息。我们的目标是迈出重要的一步，将我们广泛的实验室经验转化为术中设备的开发，以基于这些电学特性来评估手术切缘状态。我们建议构建一种EIS探针，在近显微分辨率下感知和成像前列腺及其周围组织，以努力为外科医生提供对边缘病理的实时评估。我们的研究所采用了机器人辅助的微创手术方法，我们计划设计这种探头来连接这个系统。手术可视化是通过内窥镜光学系统提供的，我们旨在使用该系统将测量的电特性记录到所探测的精确解剖位置。探头和可视化工具将被耦合到一个集成术中系统中，该系统将为外科医生提供对探头定位和测量获取的控制。该探头将在一系列体外人类前列腺标本上进行评估，并将在一系列接受RP手术的患者中使用完全集成的系统。我们的长期目标是开发这一工具，以便在手术切缘最常见的阳性部位周围检测到前列腺的电特性，包括顶缘、基缘和神经血管束缘(当进行神经保留手术时)。通过感知这些手术切缘而获得的新的术中信息有可能减少PSM的数量，这将1)降低与前列腺癌复发相关的死亡率，2)减少本应具有手术切缘的患者与辅助和挽救治疗相关的发病率，以及3)减少与癌症复发相关的患者和医疗保健提供者的经济负担。 公共卫生相关性：在根治性前列腺切除术过程中测量手术切缘的电特性可能会提醒外科医生注意未完全切除的癌症区域，从而减少与前列腺癌复发显着相关的手术切缘阳性的数量。本文提出的术中电特性传感/成像探头和可视化工具将为测量这些手术切缘提供一种准确、快速和经济有效的方法。总体而言，这将进一步推进活体正常和病变前列腺电特性特征的研究，并有助于将这项技术转化为临床。

DESCRIPTION (provided by applicant): No clinical protocols are routinely used to intraoperatively assess surgical margin status during prostate surgery. Instead, margins are evaluated through pathological assessment of the prostate following radical prostatectomy (RP), when it is too late to provide additional surgical intervention. Positive surgical margins (PSMs) are indications for disease recurrence and suggest noxious adjuvant or salvage therapies. Between 10,000 and 40,000 men each year are diagnosed with recurrent prostate cancer due to cancer cells remaining following RP. Clearly, an intraoperative device able to assess surgical margin status has the potential to provide immediate impact to patient care. Significantly different electrical property signatures have been observed between benign and malignant prostate tissues, and we hypothesis that gauging these properties intraoperatively has the potential to provide clinically relevant information regarding surgical margin pathology. We aim to take the significant step of translating our extensive laboratory experience to the development of an intraoperative device to assess surgical margin status based on these electrical properties. We propose constructing an EIS probe to sense and image at near microscopic resolution the prostate and surrounding tissues during RP in an effort to provide surgeons with real-time assessment of margin pathologies. A robot- assisted minimally invasive approach for RP is employed at our Institution and we plan to design this probe to interface with this system. Surgical visualization is provided through an endoscopic optical system which we aim to use for registering the measured electrical properties to the precise anatomic locations probed. The probe and visualization tools will be coupled into an integrated intraoperative system which will provide a surgeon control of probe positioning and measurement acquisition. The probe will be evaluated on a series of ex vivo human prostate specimens and the fully integrated system will be employed intraoperatively in a series of patients undergoing RP procedures. Our long-term vision is to develop this tool so that the electrical properties of prostate will be sensed around sites most often noted for positive surgical margins including the apical margin, base margin, and neurovascular bundle margin (when nerve sparing procedures are performed). The new intraoperative information acquired by sensing these surgical margins has the potential to reduce the number of PSMs which will 1) reduce the mortality rate associated with prostate cancer recurrence, 2) reduce the morbidities associated with adjuvant and salvage therapies in patients who would have had positive surgical margins, and 3) reduce the financial burdens to the patient and healthcare providers associated with cancer recurrence. PUBLIC HEALTH RELEVANCE: Gauging electrical properties of surgical margins during radical prostatectomy procedures has the potential to alert surgeons to regions of cancer not fully extracted and subsequently reduce the number of positive surgical margins which are significantly correlated with prostate cancer recurrence. The intraoperative electrical property sensing/imaging probe and the visualization tools proposed here will provide an accurate, rapid, and cost-effective method for gauging these surgical margins. Overall, this will further advance the study of electrical property signatures of normal and diseased prostate in vivo and help to translate this technology to the clinic.