Pre-clinical validation and verification of a biology-guided radiation therapy system

生物学引导放射治疗系统的临床前验证和验证

• 批准号: 9897028
• 负责人: Samuel Mazin
• 金额: $ 105万
• 依托单位: REFLEXION MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-06 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9897028
• 关键词: Accreditation; Articular Range of Motion; Biological; Biology; Calibration; Cancer Patient; Clinical; Clinical Data; Data Set; Development; Devices; Disease; Dose; Effectiveness; Ensure; Evaluable Disease; Film; Funding; Goals; Gold; Image; Individual; Interruption; Knowledge; Laboratories; Lesion; Location; Lung; Malignant Neoplasms; Measures; Medical; Methodology; Methods; Molecular Conformation; Motion; Movement; Neoplasm Metastasis; Operative Surgical Procedures; Outpatients; Patients; Performance; Phase; Positioning Attribute; Positron-Emission Tomography; Procedures; Prostate; Radiation; Radiation Dose Unit; Radiation therapy; Radiosurgery; Reflex action; Reproducibility; Respiration; Sensitivity and Specificity; Site; Structure; System; Techniques; Technology; Testing; Time; Tissues; Toxic effect; Tumor Volume; Validation; Variant; Work; base; cancer imaging; cancer type; chemotherapy; clinical risk; commercialization; digital; dosimetry; imaging modality; improved; indexing; innovation; novel; oncology; pre-clinical; prototype; quality assurance; response; simulation; success; treatment planning; tumor; verification and validation

Project Summary Ablative radiotherapy is an effective way to non-invasively destroy a tumor. This high-dose treatment, however, requires precise targeting, which is complicated by the fact that tumors in the body move with respiration. There are a variety of technologies that implement tumor tracking to achieve ablative radiotherapy in the body. However, these are limited to treating just a few lesions in a patient due to the complexity and invasiveness of the necessary motion management techniques. Therefore, patients that present with later-stage disease with more than a few metastatic sites (i.e., more than 3 lesions) are not feasibly treatable with ablative radiotherapy. RefleXion Medical is developing the first universal method for direct real-time targeting of tumors based on biological guidance. Utilizing positron emission tomography (PET) emissions from the patient, this new technique allows for continuous and automatic dose conformation to multiple lesions, enabling dose escalation to the target(s) and toxicity reduction to sensitive tissues. The concept has been proven with the development of the first prototype machine. This proposal has four specific aims. Aims 1 and 2 are to validate the reproducibility and robustness of the treatment approach; Aims 3 and 4 are to develop a quality assurance (QA) device that can measure the performance of biology-guided radiotherapy (BgRT) and perform end-to-end tests to validate that planning goals can be accurately achieved in patient-like phantoms. Success of these aims will mitigate clinical risks and enable commercialization of the first biology-guided radiotherapy (BgRT) system.

项目概要 消融放射治疗是一种非侵入性破坏肿瘤的有效方法。然而，这种高剂量治疗， 需要精确的靶向，而体内的肿瘤随着呼吸而移动，这一事实使情况变得复杂。 有多种技术可以实现肿瘤追踪以实现体内消融放射治疗。 然而，由于治疗的复杂性和侵入性，这些仅限于治疗患者的少数病变。 必要的运动管理技术。因此，患有晚期疾病的患者 超过几个转移部位（即超过 3 个病灶）无法通过消融放疗进行治疗。 ReflexXion Medical 正在开发第一种基于肿瘤直接实时靶向的通用方法 生物指导。利用患者的正电子发射断层扫描 (PET) 发射，这种新方法 该技术允许对多个病变进行连续和自动的剂量构象，从而实现剂量递增 对目标和减少对敏感组织的毒性。这个概念已经随着发展得到验证 第一台原型机。该提案有四个具体目标。目标 1 和 2 是验证 治疗方法的可重复性和稳健性；目标 3 和 4 是建立质量保证 (QA) 设备，可以测量生物引导放射治疗 (BgRT) 的性能并执行端到端 进行测试以验证计划目标可以在类似患者的模型中准确实现。这些的成功 目标将减轻临床风险并实现首个生物引导放射治疗（BgRT）的商业化 系统。