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: 9901490
• 负责人: Samuel Mazin
• 金额: $ 95万
• 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/9901490
• 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; Oncology; 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; 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.

项目摘要 消融放射治疗是一种有效的非侵入性破坏肿瘤的方法。然而，这种高剂量的治疗， 需要精确的靶向，这是复杂的事实，肿瘤在体内移动与呼吸。 有多种技术可以实现肿瘤跟踪，以实现体内的消融放射治疗。 然而，由于治疗的复杂性和侵入性，这些仅限于治疗患者中的少数病变。 必要的运动管理技术。因此，患有晚期疾病的患者， 多于几个的转移部位（即，多于3个病变）不能用消融性放射疗法进行治疗。 RefleXion Medical正在开发第一种用于直接实时靶向肿瘤的通用方法， 生物学指导。利用患者的正电子发射断层扫描（PET）发射， 该技术允许对多个病变进行连续和自动剂量调整， 降低对敏感组织的毒性。这一概念已被证明与发展 第一台机器的原型。这项建议有四个具体目标。目标1和2是验证 治疗方法的重现性和稳健性;目标3和4是制定质量保证 (QA)可以测量生物引导放射治疗（BgRT）性能并进行端到端 验证计划目标可以在类似患者的幻象中准确实现的测试。成功之 目的是降低临床风险，使第一个生物引导放射治疗（BgRT）商业化 系统

项目成果

Biology-guided radiotherapy: redefining the role of radiotherapy in metastatic cancer.

• DOI: 10.1259/bjr.20200873
• 发表时间: 2021-01-01
• 期刊: The British journal of radiology
• 作者: Shirvani SM;Huntzinger CJ;Melcher T;Olcott PD;Voronenko Y;Bartlett-Roberto J;Mazin S
• 通讯作者: Mazin S