SBIR Phase I: Radiolucent Ultrasound Device for Real-Time Volumetric Guidance of Radiation Therapy

该小型企业创新研究（SBIR）第一阶段项目旨在开发一种新型超声设备，以提高癌症治疗放射治疗的精确度。在外部射束放射治疗（EBRT）中，必须精确地递送具有最小治疗边缘的高效力放射剂量，以最大化局部肿瘤控制的机会并最小化周围健康组织的毒性。这种递送基于能够在放射治疗期间准确跟踪和校正实时解剖运动的系统。所提出的装置是用于使用实时超声图像信息引导辐射束的较大系统的组成部分。项目团队将制造申报器械，并通过评价体模中的超声性能指标、CT图像中伪影的严重程度、直接辐射暴露期间的成像性能以及在射束规划过程中考虑器械密度的能力来评估其可行性。如果成功，拟议的研究将导致一个新的低成本的成像设备，提供前所未有的实时软组织EBRT指导在2.5毫米的精度，而不施加任何限制现有的规划和交付practices.The边界的影响/商业潜力，这个项目是实现？圣杯？EBRT：在没有基准标记的情况下，在射束输送期间进行实时成像和肿瘤运动管理。EBRT用于治疗全球一半以上的癌症患者。水流？黄金标准？EBRT引导的解决方案依赖于使用X射线图像跟踪植入的基准标记，但是包括标记迁移、额外的电离辐射暴露和植入发病率的限制严重限制了其实用性。在临床受益方面，本提案中的指导方法具有显著的潜力，可降低健康组织毒性并提高局部肿瘤控制率，同时消除标记物植入和额外电离辐射暴露。该SBIR中开发的成像技术也可应用于超低成本、便携式4D成像，用于现场诊断、多模态诊断成像以及指导放射治疗以外的其他医疗干预。

This Small Business Innovation Research (SBIR) Phase I project seeks to develop a novel ultrasound device for improving the precision of radiation therapy delivery for cancer treatment. In external beam radiation therapy (EBRT), highly potent radiation doses with minimal treatment margins must be precisely delivered to maximize chances of local tumor control and minimize toxicity of surrounding healthy tissue. Such delivery is predicated on systems that can accurately track and correct for real-time anatomy motion during radiation treatment. The proposed device is an integral part of a larger system for guiding radiation beams using real-time ultrasound image information. The project team will fabricate the proposed device and assess its feasibility by evaluating ultrasound performance metrics in phantoms, severity of artifacts in CT images, imaging performance during direct radiation exposure, and ability to account for device density in the beam planning process. If successful, the proposed research will result in a new low-cost imaging device that provides unprecedented real-time soft-tissue EBRT guidance at 2.5 mm accuracy without imposing any restrictions on existing planning and delivery practices.The boarder impact/commercial potential of this project is to achieve the ?holy grail? of EBRT: real-time imaging and tumor motion management during beam delivery without fiducial markers. EBRT is used to treat over half of all cancer patients worldwide. The current ?gold standard? solution for EBRT guidance relies on tracking of implanted fiducial markers using x-ray images, but limitations including marker migration, additional ionizing radiation exposure, and implantation morbidity severely limit its utility. In terms of clinical benefit, the guidance approach in this proposal has significant potential to reduce healthy tissue toxicity and increase local tumor control rates while eliminating marker implantation and extra ionizing radiation exposure. Imaging technology developed in this SBIR can also apply to ultra-low cost, portable 4D imaging for field diagnosis, multi-modality diagnostic imaging, and guidance for other medical interventions outside radiation therapy.