Electrical Property Based Image-guided Prostate Biopsy

描述(由申请人提供)：本申请涉及广泛的挑战领域(06)：使能技术和具体的挑战主题，06-EB-101：微创图像引导系统的发展。该计划的主要目标是将现有的技术结合到一个多模式图像引导系统中，以提高前列腺活检和疾病分期的准确性。目前使用的经直肠超声(TRUS)引导的前列腺活检程序漏掉了高达30%的所有癌症，并且无法准确地衡量疾病的范围和侵袭性。我们团队最近的研究表明，恶性和良性前列腺组织之间存在的显著电特性差异提供了超过常规使用的传感和成像技术(包括TRUS)的对比度水平。我们建议将我们开发的电学特性成像和传感设备集成到临床接受的标准TRUS引导的活检程序中，以改进前列腺癌的检测和分期。在两个单独资助的项目中，我们开发了1)电阻抗成像(EII)设备，该设备将灵活的电极阵列直接连接到临床TRUS探头，以提供共同注册的超声(US)和电特性图像，以及2)集成到标准18号前列腺活检(Bx)针中的电阻抗频谱(EIS)传感器，以便在提取组织芯的同时检测内部前列腺电特性。我们推测，通过在图像引导的前列腺活检过程中结合使用这些模式，临床医生将增强局灶性病变的检测和识别，并改善对前列腺内病变范围和侵袭性的评估。在该计划期间，EII-TRUS和EIS-Bx数据采集将同步，使用EIS-Bx测量的前列腺内电属性将被合并到用于从EII重建电属性图像的算法中。该算法将在高速图形处理单元上实现，为临床部署提供接近实时的成像。为了将这项技术迅速应用于临床，多模式图像引导系统将在我们机构的一系列常规活检过程中使用，以评估前列腺电特性提供的临床成像潜力。由于这些设备被设计为最小限度地增加现有的和临床接受的设备，相对便宜(EII系统&lt；1万美元，每个EIS-Bx设备&lt；100美元，批量生产)，并且能够以高度的灵敏度和特异性识别恶性前列腺，这项技术有可能很容易被转化为临床并被临床接受，以造福于怀疑患有前列腺癌的男性。我们希望在这个为期两年的计划结束时，我们能够进行一项更大规模的临床试验，评估该系统为常规前列腺活检提供的额外好处。该项目利用了我们集团在电阻抗传感和成像方面的丰富临床经验。 公共卫生相关性：目前使用经直肠超声(TRUS)成像引导前列腺活检的临床实践不幸遗漏了高达三分之一的癌症，并且没有准确地识别这种疾病的临床意义。前列腺癌和正常组织的组织结构相关的电学特性有很大的不同，提供的对比度远远超过TRUS。我们的目标是在活检过程中对这些特性进行成像，以便对前列腺癌内容物提供更准确的实时临床评估，并评估当检测到这些电特性时，可实现的疾病检测和分期的收益。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (06): Enabling Technologies and specific Challenge Topic, 06-EB-101: Development of minimally invasive image-guided systems. The primary goal of this program is to couple already existing technologies into a multi-modal image-guidance system to improve the accuracy of prostate biopsy and disease staging. Currently employed transrectal ultrasound (TRUS)-guided prostate biopsy procedures miss up to 30% of all cancers and are not able to accurately gauge the extent and aggressiveness of the disease. Recent studies by our group have shown that significant electrical property differences existing between malignant and benign prostate tissues provide levels of contrast exceeding those of routinely employed sensing and imaging technologies including TRUS. We propose to integrate electrical property imaging and sensing devices we have developed into a standard clinically accepted TRUS-guided biopsy procedure to improve prostate cancer detection and staging. In two separately funded projects, we have developed 1) an electrical impedance imaging (EII) device that couples a flexible array of electrodes directly to a clinical TRUS probe to provide co-registered ultrasound (US) and electrical property images and 2) an electrical impedance spectroscopy (EIS) sensor integrated into a standard 18-gauge prostate biopsy (Bx) needle to permit sensing of internal prostatic electrical properties in tandem with tissue core extraction. We hypothesize that by coupling these modalities for use during image-guided prostate biopsy procedures a clinician will have enhanced focal lesion detection and identification and improved assessment of disease extent and aggressiveness within the prostate. During this program, EII-TRUS and EIS-Bx data acquisition will be synchronized, and the intra-prostatic electrical properties gauged with EIS-Bx will be incorporated into the algorithm used to reconstruct electrical property images from EII. This algorithm will be implemented on high speed graphical processing units to provide near real-time imaging for clinical deployment. In an effort to rapidly translate this technology to the clinic, the multi-modal image-guidance system will be used during a series of routine biopsy procedures at our institution in order to assess the clinical potential imaging the electrical properties of prostate provides. Because these devices were designed to minimally augment already existing and clinically accepted instruments, are relatively inexpensive (<$10k for an EII system and <$100 for each EIS-Bx device, production quantities), and are able to identify malignant prostate with a high degree of sensitivity and specificity, this technology has the potential of being easily translated to and accepted by the clinic for the benefit of men suspected of having prostate cancer. We expect that by the end of this two-year program we will be in a position to conduct a much larger clinical trial evaluating the added benefit this system provides to routine prostate biopsy. This project capitalizes on our group's extensive clinical experience in electrical impedance sensing and imaging. PUBLIC HEALTH RELEVANCE: Current clinical practices using trans-rectal ultrasound (TRUS) imaging to guide prostate biopsy unfortunately miss up to a third of all cancers and do not accurately identify the clinical significance of the disease. The tissue-structure dependent electrical properties of prostate are significantly different in cancer and normal tissue and provide levels of contrast that far exceed those of TRUS. We aim to image these properties during biopsy procedures in order to provide more accurate real-time clinical assessment of cancer content within the prostate and evaluate the gains achievable for disease detection and staging when these electrical properties are sensed.