Devices enabling improved light delivery for photodynamic therapy of oral cancer

描述(由申请者提供)：口腔癌是一种毁灭性的疾病，影响着全球64万人。虽然光动力疗法的治疗效果明显优于其他疗法，但由于光传输到口腔的效果不佳而导致的问题阻碍了光动力疗法的广泛应用。拟议研究的目标是提供一类新的有效、负担得起和方便的一次性使用资源。这些设备将克服目前设备的限制，向治疗区域和边缘提供统一的辐射，从而产生更可预测和更可重复性的临床结果。此外，通过为口腔正常组织提供固有的屏蔽，它们将极大地减少为患者准备PDT会议所需的时间和精力。在拟议研究的第二阶段，将为预期的临床评估建造一套最初的12个设备。这些药物将被量身定做，用于治疗常见的口腔癌部位，包括舌侧缘、舌腹、牙床和口底。源设计将利用初步研究中建立的概念验证工程，每个产生的设备都将进行辐射特性表征。设备性能将在基于图形处理器单元的蒙特卡罗模拟中建模，该模拟将明确地合并辐射测量数据，并表征以前未报道的源-组织反馈机制。在这项为期一年的调查结束时，我们将能够测试这些设备 与罗斯威尔公园癌症研究所合作进行临床评估。 公共卫生相关性：应用光动力疗法(PDT)治疗口腔癌是有效的，与其他治疗方式相比具有许多治疗优势。然而，现有的PDT光源临床上的不便限制了它的广泛应用。拟议的调查旨在提供廉价和方便的一次性来源，以提供均匀的辐射和固有的正常组织屏蔽。

DESCRIPTION (provided by applicant): Oral cancer is a devastating disease that impacts 640,000 people worldwide. Though treatment with photodynamic therapy can be effective with significantly less morbidity than alternative therapies, problems arising from less than optimal light delivery to the oral cavity have hindered its widespread application. The goal of the proposed research is to provide a new class of single-use sources that are effective, affordable and convenient. These devices will overcome current device limitations to deliver a uniform irradiance to the treatment region and margin, resulting in more predictable and reproducible clinical outcome. Also, by providing inherent shielding of normal tissues of the oral cavity, they will greatly reduce the time and effort needed to prepare a patient for a PDT session. An initial set of 12 devices will be constructed for an anticipated clinical evaluation in Phase II of the proposed investigation. These will be tailored to treat common oral cancer sites including the lateral border of the tongue, ventral tongue, gumlineand floor of the mouth. The source design will leverage proof-of-concept engineering established in the preliminary studies, and each resulting device will be characterized radiometrically. Device performance will be modeled in a graphical-processor-unit based Monte Carlo simulation that will explicitly incorporate the radiometric data and characterize a previously unreported source-tissue feedback mechanism. At the conclusion of this one-year investigation, we will be in a position to subject these devices to clinical evaluation in collaboration with Roswell Park Cancer Institute. PUBLIC HEALTH RELEVANCE: The application of photodynamic therapy (PDT) for the treatment of oral cancers is effective with many therapeutic advantages over other treatment modalities. Clinical inconveniences of available PDT light sources, however, have limited its widespread adoption. The proposed investigation seeks to provide inexpensive and convenient single-use sources that will provide uniform irradiance and inherent normal tissue shielding.