Robotic Ultrasound Image Guidance System for Radiation Therapy

描述（由申请人提供）：外部束放射治疗（EBRT）用于全球一半以上的癌症患者的疾病管理。为了推进EBRT领域并改善治疗结果，必须给予高度适形的强效烧蚀剂量，以最大限度地控制局部肿瘤并将对周围健康组织的毒性降到最低。随机和准周期性的解剖运动是实现这种一致性的根本威胁，从而限制了EBRT的治疗潜力。现有的和新兴的在束传送过程中定位腹部目标的技术包括跟踪植入的基准标记物、跟踪外部替代物或通过磁共振图像引导。然而，这些技术无法为现有的辐射输送平台提供实时、体积、非侵入性、无标记的软组织图像引导能力。因此，提高EBRT的技术能力和临床效果存在重大的科学和商业机会。我们的愿景是通过追求一种新颖的EBRT图像引导方法，将实时体积（4D）超声（US）与机器人技术相结合，来实现这一机会。在设想的产品中，使用定制的微创机器人机械手连续获得目标解剖的软组织图像，该机械手设计用于控制4D US探头对患者的位置和力。在治疗前和治疗期间，组织位移在空间定位的US图像中被跟踪，并用于指导精确的患者定位和EBRT输送到目标。在这项I期小企业技术转移拨款中，SoniTrack Systems提议通过以下方式建立该产品的商业可行性：(1)证明机器人4D US系统用于腹部和盆腔癌患者成像的鲁棒性；(2)展示了两种有效的策略来考虑放射治疗设计中的图像引导系统硬件；(3)利用多平面和体积US成像演示目标位置的实时3D跟踪。这些目标的实现将消除与拟议产品相关的主要技术和临床风险。SoniTrack将该产品商业化，使治疗能够真正适应放射束输送过程中内部软组织解剖结构的持续变化，从而改变放射治疗领域。

DESCRIPTION (provided by applicant): External Beam Radiation Therapy (EBRT) is used in the disease management of more than half of all cancer patients worldwide. In order to advance the field of EBRT and improve treatment outcomes, highly conformal, potent ablative doses must be delivered to maximize local tumor control and minimize toxicity to surrounding healthy tissue. Random and quasi-periodical anatomy motion during beam delivery poses a fundamental threat to realizing such conformity, and thus restricts the curative potential of EBRT. Existing and emerging technologies for localizing abdominal targets during beam delivery employ tracking of implanted fiducial markers, tracking of external surrogates, or guidance via magnetic resonance images. However, these technologies cannot provide real-time, volumetric, non-invasive, markerless soft-tissue image guidance capabilities to existing radiation delivery platforms. Thus a significant scientific and commercial opportunity exists to improve the technical capability and clinical outcomes of EBRT. Our vision is to realize this opportunity by pursuing a novel EBRT image guidance approach combining real-time volumetric (4D) ultrasound (US) with robotic technology. In the envisaged product, soft-tissue images of target anatomy are continuously obtained using a customized, minimally-invasive robotic manipulator designed to control the position and force of a 4D US probe against the patient. Before and during treatment, tissue displacements are tracked in spatially localized US images and used to guide precise patient positioning and EBRT delivery to the target. In this Phase I Small Business Technology Transfer grant, SoniTrack Systems proposes to establish the commercial feasibility of such a product by: (1) demonstrating the robustness of the robotic 4D US system for imaging abdominal and pelvic cancer patients; (2) demonstrating two effective strategies to account for image guidance system hardware in radiation treatment designs; and (3) demonstrating real-time 3D tracking of target sites with multi-plane and volumetric US imaging. Accomplishment of these objectives will remove the main technological and clinical risks related to the proposed product. Commercialization of the product by SoniTrack can transform the radiation therapy field by enabling treatments that are truly adaptive to the continuous changes of internal soft-tissue anatomy during radiation beam delivery.