BIOPSY NEEDLE FOR TUMOR BLOOD FLOW QUANTIFICATION

该项目寻求将血流(灌注)传感器与核心和抽吸活组织检查针结合起来。集成装置的可行性在第一阶段利用体内的黄金标准微球技术进行了明确的论证和验证。这种设备(针头、传感器、仪器和软件)将成为研究肿瘤血流/氧合与抗肿瘤治疗结果之间关系的工具。由于灌注是氧的载体，氧是放疗和化疗的调节剂，因此灌注对这些治疗的结果起着重要的作用。目前还没有一种工具可以常规评估肿瘤的血流灌注。这种低成本的设备将提供有关肿瘤血流调节剂成功的信息，帮助计划抗肿瘤治疗以实现最大效果，并确保活检取自诊断的非坏死性组织。此外，它将收集血流灌注数据，而不会增加患者的发病率，也不会增加在正常周围组织中种植肿瘤细胞的风险，而不是标准的活检程序。在第二阶段，将设计和开发活检灌注探头，以及用于独立计算机/仪器的控制电子和数据分析算法。整个系统将在肿瘤模型中对照微球技术进行验证，并将量化改变肿瘤血流的能力。拟议的商业应用：用于测量肿瘤血流量的仪表式活检针有可能预测美国每年数十万患者的非手术抗肿瘤治疗的疗效。这种设备应该会在许多研究动物模型和人类肿瘤血流的研究中心得到广泛应用。一种低成本的活检针附件，可以量化组织活力和组织缺血，并允许检测针尖附近的血管以帮助导航，预计将具有巨大的商业潜力。

This project seeks to incorporate blood flow (perfusion) sensors with core and aspiration biopsy needles. The feasibility of the integrated device was unambiguously demonstrated and validated in Phase I using the gold- standard microsphere technique in vivo. This device (needle, sensor, instrument and software) will serve as a tool to investigate the relationship between tumor blood flow/oxygenation and anti-tumor therapy outcome. Since perfusion is the carrier of oxygen which is a modifier of radiotherapy and chemotherapy, perfusion plays a significant role in the outcome of these therapies. There does not exist a tool to routinely assess tumor perfusion. This low cost device will provide information about the success of tumor blood flow modification agents, to help plan anti-tumor therapy for maximal effectiveness and to ensure that the biopsy is taken from diagnostic, non- necrotic tissue. Also it will collect perfusion data without increased patient morbidity nor increased risk for seeding the normal surrounding tissue with tumor cells over that of a standard biopsy procedure. In Phase II, biopsy perfusion probes will be designed and developed along with the controlling electronics and data analysis algorithms for use in a stand- alone computer/instrument. This entire system will be validated in a tumor model against the microsphere technique and the ability to modify tumor blood flow will be quantified. PROPOSED COMMERCIAL APPLICATION: The instrumented biopsy needle for the measurement of tumor blood flow has the potential to predict the efficacy of non-surgical anti-tumor therapy for hundreds of thousands of patients in the US each year. This device should find wide application in many research centers studying tumor blood flow in animal models and humans. A low-cost biopsy needle adjunct which quantifies tissue viability and tissue ischemia, and permits sensing of vessels in close proximity to the needle tip to aid in navigation, is expected to have great commercial potential.