Robotic Ultrasound Image Guidance System for Radiation Therapy

描述（由申请人提供）：外部射束放射治疗（EBRT）用于全球一半以上癌症患者的疾病管理。为了推进EBRT领域并改善治疗结果，必须输送高度适形的有效消融剂量，以最大限度地控制局部肿瘤并最大限度地减少对周围健康组织的毒性。射束输送过程中随机和准周期性的解剖运动对实现这种一致性构成了根本威胁，从而限制了EBRT的治疗潜力。用于在射束递送期间定位腹部目标的现有和新兴技术采用植入的基准标记的跟踪、外部替代物的跟踪或经由磁共振图像的引导。然而，这些技术不能向现有的辐射递送平台提供实时、体积、非侵入性、无标记的软组织图像引导能力。因此，存在一个重要的科学和商业机会，以提高EBRT的技术能力和临床结果。我们的愿景是实现这一机会，通过追求一种新的EBRT图像引导方法结合实时体积（4D）超声（US）与机器人技术。在设想的产品中，使用定制的微创机器人操纵器连续获得目标解剖结构的软组织图像，该机器人操纵器设计用于控制4D US探头对患者的位置和力。在治疗之前和治疗期间，在空间定位的US图像中跟踪组织位移，并用于指导精确的患者定位和EBRT输送到目标。在第一阶段的小企业技术转让赠款中，SoniTrack Systems建议通过以下方式建立此类产品的商业可行性：（1）证明机器人4D US系统用于腹部和盆腔癌症患者成像的稳健性;（2）证明两种有效的策略，以说明放射治疗设计中的图像引导系统硬件;以及（3）演示利用多平面和体积US成像对目标部位的实时3D跟踪。实现这些目标将消除与申报产品相关的主要技术和临床风险。SoniTrack产品的商业化可以通过使治疗真正适应放射束输送期间内部软组织解剖结构的持续变化来改变放射治疗领域。

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.