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 放射治疗是一种补充治疗疗法，用于大多数手术和化学疗法， 一生中每4人中每4个人中近1个人。外束治疗通常是 分馏（即每天交付25-40天）。虽然通常被认为是安全有效的，但许多 在田野里，认为这可能更安全。如果不服用高度每天给药，可能会发生主要的潜在副作用 精度，包括毫米水平的患者对齐和护理以保持正常组织剂量足够低。 然而，这种治疗中有1-5％的继发性癌症发生率为1-5％。这特别重要 在乳房放射疗法中，即使对对侧乳房的1％剂量也被证明会导致高 继发性癌症的概率。实际上，没有诊所实际上知道他们的真实事件，因为没有系统 存在可视化每种治疗方法作为常规临床实践的一部分。 Beamsitetm系统的发明， 对于时间门控的Cherenkov光排放的单光子光子成像，提供了第一个直接视频成像 辐射剂量的递送。该系统实时捕获了交付事件的直接可视化， 因此，可以由治疗师进行直观的观察，并且可以根据需要进行每日更正。在 该应用程序，我们将进行一项多中心临床研究，以研究Cherenkov成像的能力 检测事件，迄今为止，将无法检测到的事件。我们还将通过 自动化事件检测工具使梁siTETM轻松地由治疗团队使用。最后，系统将 还可以通过剂量估计算法扩展，以估计长期继发性癌症风险。该项目是 根据以前的NIH支持的硬件，即FDA 510（k）进行营销，并将部署 随着这里提出的工具的增强。当前的建议为目标提供了资源：（i） 量化多种放疗临床环境中患者的总体治疗中的错误率，以及（ii）量化 计划外剂量输送到非目标组织，包括整个乳房放射疗法中的对侧乳房。 这项工作包括软件支持和光学闪烁剂剂量计的开发，并将 这些目标。对事件率的前瞻性人类研究将作为多站点的努力进行 达特茅斯 - 希区柯克卫生医疗中心。该系统产生的数据将证明 治疗的可视化可以改变跟踪日常放射疗法的方式，并为连续的工具提供工具 每个参与中心的改进，从而降低了靶向辐射的次要发病率。 存在财务报销，并且随着现场转移到基于质量的报销与基于数量的基于质量的报销， Cherenkov成像将成为所有领先的放射疗法单元的主食。