Robotic Ultrasound Image Guidance System for Radiation Therapy

描述(申请人提供)：外照射疗法(EBRT)用于治疗全世界超过一半的癌症患者。为了推进EBRT领域和改善治疗结果，必须提供高度适形、有效的消融剂量，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至最低。电子束投射过程中的随机和准周期解剖运动对实现这种顺应性构成了根本威胁，从而限制了EBRT的治疗潜力。现有的和新兴的在射束传输过程中定位腹部目标的技术使用了对植入的基准标记的跟踪、对外部替代物的跟踪或通过磁共振图像的引导。然而，这些技术不能为现有的放射传递平台提供实时、体积、非侵入性、无标记的软组织图像引导能力。因此，改善EBRT的技术能力和临床结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的EBRT图像引导方法来实现这一机会，该方法将实时体积超声(US)与机器人技术相结合。在设想的产品中，使用定制的微创机器人操作器连续获得目标解剖的软组织图像，该操作器旨在控制4D US探头对患者的位置和力。在治疗前和治疗期间，在空间定位的US图像中跟踪组织移位，并用于指导精确的患者定位和EBRT向目标提供。在第一阶段的小企业技术转让赠款中，SoniTrack系统公司建议通过以下方式确定这种产品的商业可行性：(1)展示用于腹部和盆腔癌症患者成像的机器人4D US系统的健壮性；(2)展示在放射治疗设计中考虑图像引导系统硬件的两种有效策略；以及(3)展示利用多平面和体积超声成像对目标部位进行实时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，可以使治疗真正适应放射束传输期间内部软组织解剖的持续变化，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.