Everyday Use of Optical Cherenkov Imaging Identifies Adverse Events and Opportunities for Improved Radiation Treatment

光学切伦科夫成像的日常使用可识别不良事件和改进放射治疗的机会

• 批准号: 10474573
• 负责人: William Ware
• 金额: $ 100万
• 依托单位: DOSEOPTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-24 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10474573
• 关键词: Adjuvant; Adverse event; Algorithms; Anatomy; Area; Assessment tool; Breast; Breathing; Cancer Patient; Caregivers; Caring; Clinic; Clinical; Collaborations; Computer software; Contralateral Breast; Data; Detection; Development; Documentation; Dose; Elements; Engineering; Event; Funding; Future; Goals; Grant; Health; Hospitals; Image; Incidence; Insurance; Intuition; Ions; Lead; London; Marketing; Measures; Medical center; Morbidity - disease rate; Multi-site clinical study; Normal tissue morphology; Operative Surgical Procedures; Optics; Outcome; Patients; Pennsylvania; Persons; Phase; Photons; Pilot Projects; Positioning Attribute; Probability; Quality of Care; Radiation; Radiation Dose Unit; Radiation therapy; Recording of previous events; Registries; Reporting; Resources; Second Primary Cancers; Stream; Surface; System; Testing; Time; Tissues; United States; United States National Institutes of Health; Universities; Validation; Visualization; Washington; Work; base; cancer risk; cancer therapy; chemotherapy; cherenkov imaging; clinical practice; clinically relevant; curative treatments; dosimetry; human study; improved; invention; irradiation; light emission; millimeter; mortality; new technology; post-market; prospective; prototype; quantitative imaging; radiation delivery; research and development; side effect; tool; treatment planning

ABSTRACT Radiation therapy is a supplementary curative treatment used adjuvant with most surgery and chemotherapy, being delivered to nearly 1 out of every 4 people in their lifetime. External beam treatment is commonly fractionated (i.e. delivered every day for 25-40 days). While it is generally considered safe and effective, many in the field believe it could be safer. Major potential side effects can occur if not administered with high daily accuracy, including millimeter level patient alignment and care to keep normal tissue doses sufficiently low. However, there is a proven 1-5% incidence of secondary cancer from this treatment. This is particularly relevant in breast radiotherapy, where even a 1% dose to the contralateral breast has been proven to lead to a high probability for a secondary cancer. In reality, no clinic actually knows their true incident rate, because no system exists to visualize every treatment as part of routine clinical practice. The invention of the BeamSiteTM system, for time-gated single photon imaging of Cherenkov light emissions, provides the first direct video imaging of the radiation dose delivery as it happens. The system captures a direct visualization of delivery incidents in real time, so that intuitive observations can be made by the therapists and daily corrections can be made as needed. In this application, we will carry out a multicenter clinical study to investigate the capability of Cherenkov imaging to detect events which, heretofore, would go undetected. We will also advance the workflow of the system with automated incident detection tools to make BeamSiteTM easily used by the therapy team. Finally, the system will also be expanded with dose estimation algorithms to estimate long term secondary cancer risk. The project is based upon previous NIH supported hardware that is FDA 510(k) cleared for marketing and will be deployed with augmentation from the tools proposed here. The current proposal provides resources for the goals of: (i) quantifying error rates in the overall treatment of patients in multiple radiotherapy clinical settings, and (ii) quantify the unplanned dose delivered to non-target tissues, including contralateral breast in whole breast radiotherapy. The work includes software support and optical scintillator dosimetry development, to be leveraged towards these goals. The prospective human study of the incident rates will be carried out as a multisite effort within the Dartmouth-Hitchcock Health medical centers. The data produced with this system will demonstrate that visualization of treatment can change the way that daily radiotherapy is tracked and provide a tool for continuous improvement for each participating center, thereby reducing the secondary morbidity of off-target radiation. Financial reimbursement exists and as the field shifts to quality-based reimbursement versus quantity-based, Cherenkov imaging will become a staple of all leading radiotherapy units.

抽象的 放射治疗是一种辅助治疗方法，与大多数手术和化疗一起使用， 几乎每 4 个人中就有 1 人在其一生中被交付。外部光束处理通常是 分次（即每天交付，持续 25-40 天）。虽然它通常被认为是安全有效的，但许多 在现场相信它可以更安全。如果不每天服用高剂量的药物，可能会出现主要的潜在副作用 准确性，包括毫米级患者对准和护理以保持正常组织剂量足够低。 然而，已证实这种治疗继发性癌症的发生率为 1-5%。这一点特别相关 在乳房放射治疗中，即使对侧乳房接受 1% 的剂量，也已被证明会导致较高的放射剂量。 继发性癌症的可能性。事实上，没有一家诊所真正知道他们的真实事故率，因为没有系统 其存在是为了将每一种治疗可视化为常规临床实践的一部分。 BeamSiteTM系统的发明， 用于切伦科夫光发射的时间选通单光子成像，提供了第一个直接视频成像 发生时的辐射剂量输送。该系统实时捕获交付事件的直接可视化， 以便治疗师可以进行直观观察，并根据需要进行日常纠正。在 针对这个应用，我们将进行多中心临床研究来考察切伦科夫成像的能力 检测迄今为止未检测到的事件。我们还将推进系统的工作流程 自动化事件检测工具使治疗团队可以轻松使用 BeamSiteTM。最后，系统将 还可以通过剂量估计算法进行扩展，以估计长期继发癌症风险。该项目是 基于之前 NIH 支持的硬件，该硬件已获得 FDA 510(k) 批准上市并将被部署 通过此处建议的工具进行增强。当前提案为以下目标提供资源：(i) 量化多种放射治疗临床环境中患者整体治疗的错误率，以及 (ii) 量化 计划外的剂量传递到非目标组织，包括全乳放疗中的对侧乳房。 这项工作包括软件支持和光学闪烁体剂量测定开发，用于 这些目标。对事故发生率的前瞻性人体研究将在 达特茅斯-希区柯克健康医疗中心。该系统产生的数据将证明 治疗的可视化可以改变日常放射治疗的跟踪方式，并提供持续治疗的工具 每个参与中心的改善，从而减少脱靶辐射的继发性发病率。 财务报销是存在的，并且随着该领域转向基于质量的报销而不是基于数量的报销， 切伦科夫成像将成为所有领先放射治疗设备的主要设备。