Bringing 4π radiation therapy to the clinic

将 4° 放射治疗引入诊所

• 批准号: 10464360
• 负责人: Ke Sheng
• 金额: $ 113.23万
• 依托单位: CELESTIAL ONCOLOGY INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-06 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10464360
• 关键词: Adoption; Algorithms; Automation; Award; Back; Businesses; Cancer Patient; Clinic; Clinical; Clinical Research; Computer software; Development; Disease; Dose; Extravasation; Fluoroscopy; Freedom; Funding; Grant; Head; Image; Investments; Lead; Life; Linear Accelerator Radiotherapy Systems; Lung Neoplasms; Malignant neoplasm of lung; Maps; Mathematics; Mechanics; Motion; Names; Oncology; Organ; Patients; Phase; Preparation; Publications; Radiation Dose Unit; Radiation Tolerance; Radiation therapy; Radiometry; Risk; Robot; Robotics; Roentgen Rays; Savings; Series; Site; Small Business Innovation Research Grant; Solid; Source; System; Systems Integration; Testing; Three-Dimensional Image; Three-Dimensional Imaging; Time; Toxic effect; Translating; United States National Institutes of Health; Validation; arm; base; cancer therapy; clinical application; cohort; commercialization; design; detector; dosimetry; flexibility; image guided; image guided radiation therapy; imaging modality; improved; innovation; novel; reconstruction; research and development; response; robotic system; success; tumor; verification and validation

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.

意义/创新：在放射治疗中使用非共面光束可以显着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，这种治疗的最佳效果需要广泛的 以及有效利用与现有放射治疗平台不兼容的非共面光束。这 广泛使用的 C 形臂龙门系统容易碰撞、笨重，并且需要不理想的患者床 运动以获得非共面角度。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极为有限， 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推动，加州大学洛杉矶分校 (UCLA) 和 RadiaBeam 正在开发一种新型机器人 名为 Polaris 的放射治疗平台克服了现有放射治疗系统的局限性， 具有以下创新优势： 1. 超紧凑的6MV直线加速器可无障碍访问 4π立体角，包括后梁。 2. 集成光束定向的数学框架， 源到肿瘤距离和注量图优化，可以有效地创建更好的计划 比临床最先进的。 3. 首次在无人机上实现3D图像引导系统 机器人放射治疗系统不妨碍非共面输送的自由度。 4. 的 硬件和软件的结合使卓越的剂量测定能够有效地传递到所有目标 尺寸，使我们的系统成为所有 C 臂龙门系统和现有机器人的卓越替代品 放射治疗系统作为通用放射治疗机。 在 SBIR 项目（NIH II 期 5R44CA183390-04）期间，Celestial Oncology Inc. 成立，旨在将 Polaris 系统上市，并于 2020 年获得 600 万美元 A 轮投资。这款 NIH SBIR IIB 期桥接器 项目将加速完成实现这一目标所需的最后技术、监管和临床步骤 到诊所进行挽救生命的治疗。我们提出以下目标： 目标：1a：机械同步 X 射线源和探测器机器人。 1b.收集圆形的投影 和 CBCT 重建的螺旋轨迹。 1c.集成端到端 IGRT 的成像组件 准确性验证。 2a.完成临床系统的设计、制造、验证和确认。 2b.提交美国市场审批。 2c.建立并认证质量管理体系。 3a.安装 以及 UCLA 4π 放射治疗系统的验收测试。 3b.早期临床研究。 影响：Polaris 将成为所有通用机器的卓越替代品，具有剂量优势 一致性、自动化和吞吐量。这些优势将推动快速采用。此次活动的成功 该项目将清除当前技术发展水平与所需技术之间的最后障碍 商业和临床准备就绪。