Devices enabling improved light delivery for photodynamic therapy of oral cancer

口腔癌是一种毁灭性的疾病，影响着全球64万人。虽然光动力疗法比其他替代疗法更有效且发病率更低，但由于口腔光传输不理想而引起的问题阻碍了其广泛应用。拟议研究的目标是提供一种有效、负担得起和方便的新型一次性来源。这些设备将克服当前设备的限制，为治疗区域和边缘提供均匀的辐照度，从而产生更可预测和可重复的临床结果。此外，通过提供口腔正常组织的固有屏蔽，它们将大大减少患者准备PDT会议所需的时间和精力。一套初始的12个设备将用于拟议研究的II期预期临床评估。这些将专门用于治疗常见的口腔癌部位，包括舌侧边缘、舌腹、牙龈线和口腔底部。源设计将利用初步研究中建立的概念验证工程，并且每个最终设备都将进行辐射特性分析。设备性能将在基于蒙特卡罗模拟的图形处理器单元中建模，该模拟将明确地结合辐射测量数据并表征以前未报道的源组织反馈机制。在为期一年的调查结束后，我们将能够对这些设备进行测试

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.