Bringing 4π radiation therapy to the clinic

意义/创新：在放射治疗中使用非共面射束可以显著改善放射治疗的剂量测定。 更好的正常器官保护和肿瘤靶向。然而，这种治疗的最佳性需要广泛的 以及有效利用与现有放射治疗平台不兼容的非共面射束。的 广泛使用的C形臂台架系统易于碰撞、笨重，并且需要不期望的患者床 运动以实现非共面角度。现有的机器人系统缺乏后梁和规划 系统整体优化射束方向和注量，使其在可实现的剂量测定方面受到极大限制， 目标大小、适用的疾病部位和通量。 受这些临床和市场需求的激励，UCLA和RadiaBeam正在开发一种新的机器人 放射治疗平台Polaris克服了现有放射治疗系统的局限性， 以下创新优势：1.超紧凑型6 MV直线加速器可实现无障碍访问， 4π立体角，包括后部光束。2.一种用于集成波束定向的数学框架， 源到肿瘤的距离和注量图优化，这可以有效地创建更好的计划 比最先进的临床技术更先进。3D图像引导系统将首次在 机器人放射治疗系统，而不妨碍非共面输送的自由度。4.的 硬件和软件的组合允许将上级剂量测定有效地递送到所有的目标。 尺寸，使我们的系统成为所有C形臂机架系统和现有机器人的上级替代品 放射治疗系统作为通用放射治疗机。 在SBIR项目（NIH II期5 R44 CA 183390 -04）期间，Celestial Oncology Inc.成立的目的是 Polaris系统上市，并于2020年获得600万美元的A轮投资。NIH SBIR Phase IIB桥接 该项目将加速完成最后的技术，监管和临床步骤，以实现这一目标。 拯救生命的治疗我们提出以下目标： 目的：1a：机械同步X射线源和探测器机器人。1b.收集循环的投影 以及CBCT重建的螺旋轨迹。1c.集成成像组件以实现端到端IGRT 准确性验证2a.完成临床系统的设计、制造、验证和确认。 2b.提交美国市场许可。2c.建立并认证质量管理体系。3a.安装 4π放射治疗系统在UCLA的验收测试。3b.早期临床研究。 影响：北极星将作为所有通用机器的上级替代品，在剂量方面具有优势 一致性、自动化和吞吐量。这些优势将推动快速采用。的成功 该项目将清除当前技术发展水平与未来需要之间的最后障碍。 商业和临床上都准备好了。

Significance/Innovation: Utilizing non-coplanar beams in radiotherapy can significantly improve dosimetry for better normal organ sparing and tumor targeting. However, the optimality of such therapy requires extensive and efficient utilization of non-coplanar beams that are incompatible with existing radiotherapy platforms. The widely available C-arm gantry systems are collision prone, cumbersome, and require undesirable patient couch motion to achieve the non-coplanar angles. The existing robotic system lacks posterior beams and a planning system to integrally optimize beam orientation and fluence, making it extremely limited in achievable dosimetry, target sizes, applicable disease sites, and throughput. Motivated by these clinical and market needs UCLA and RadiaBeam are developing a new robotic radiotherapy platform called Polaris that overcomes the limitations of existing radiotherapy systems, with the following innovative advantages: 1. A super compact 6MV linear accelerator enables unobstructed access to 4π solid angle, including posterior beams. 2. A mathematical framework for integrated beam orientation, source-to-tumor distance, and fluence map optimization, which can efficiently create substantially better plans than the clinical state-of-the-art. 3. A 3D image guidance system will be implemented for the first time on a robotic radiotherapy system without impeding the degrees of freedom in non-coplanar delivery. 4. The combination of hardware and software allows superior dosimetry to be efficiently delivered to targets of all sizes, making our system a superior replacement of all C-arm gantry systems and the existing robotic radiotherapy system as a general-purpose radiotherapy machine. During the SBIR project (NIH Phase II 5R44CA183390-04), Celestial Oncology Inc. was founded to bring the Polaris system to market, and received a $6M series A investment in 2020. This NIH SBIR Phase IIB bridge project will accelerate the completion of the last technical, regulatory, and clinical steps required to bring this life-saving therapy to the clinic. We propose the following aims: Aims: 1a: Mechanically synchronize the X-ray source and detector robots. 1b. Collect projections for circular and helical trajectories for CBCT reconstruction. 1c. Integrate the imaging component for end-to-end IGRT accuracy validation. 2a. Complete the design, manufacturing, verification, and validation of the clinical system. 2b. Submit for US market clearance. 2c. Establish and certify a Quality Management System. 3a. Installation and acceptance tests of the 4π radiotherapy system at UCLA. 3b. Early phase clinical study. Impact: Polaris will serve as a superior replacement of all general-purpose machines with advantages in dose conformity, automation, and throughput. These advantages will drive rapid adoption. The success of this project will clear the last hurdles between the current level of technical development and what is needed to be commercially and clinically ready.