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术中评估手术切缘状态。相反，在根治性前列腺切除术（RP）后，当提供额外的手术干预为时已晚时，通过前列腺病理评估来评估边缘。手术切缘阳性（psm）是疾病复发的指征，建议进行有害的辅助或挽救治疗。每年有1万到4万名男性被诊断为复发性前列腺癌，原因是RP术后癌细胞残留。显然，术中能够评估手术切缘状态的设备有可能为患者护理提供即时影响。在良性和恶性前列腺组织之间观察到明显不同的电特性特征，我们假设术中测量这些特性有可能提供有关手术边缘病理的临床相关信息。我们的目标是迈出重要的一步，将我们丰富的实验室经验转化为术中设备的开发，以评估基于这些电特性的手术切缘状态。我们建议构建一个EIS探针，在RP过程中以近微观分辨率感知和成像前列腺和周围组织，以努力为外科医生提供边缘病理的实时评估。我们的机构采用了机器人辅助的微创RP方法，我们计划设计该探针与该系统接口。手术可视化是通过内窥镜光学系统提供的，我们的目标是使用该系统将测量的电学特性记录到所探测的精确解剖位置。探头和可视化工具将耦合到一个集成的术中系统中，该系统将为外科医生提供对探头定位和测量采集的控制。该探针将在一系列离体人类前列腺标本上进行评估，并且完全集成的系统将在术中用于一系列接受RP手术的患者。我们的长期目标是开发这种工具，以便在最常见的阳性手术边缘（包括根尖边缘、基底边缘和神经血管束边缘）周围检测前列腺的电特性（当进行神经保留手术时）。通过感知这些手术切缘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)减少与手术切缘阳性患者的辅助和挽救性治疗相关的发病率，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。

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.