Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral

描述(申请人提供)：口腔癌占印度报告的癌症的30%以上，是世界上口腔癌发病率最高的国家之一(归因于咀嚼古特卡的广泛流行)，是印度男性癌症死亡的主要原因。总体影响是增加发病率、死亡率和经济负担。这项应用旨在通过使用低成本适应光动力疗法(PDT)来解决口腔癌问题，这是我们小组的一个活跃研究领域。这项研究的主旨是设计一种可以在没有医疗基础设施的地点使用的平台，使用电池供电的光源和智能手机以及d-氨基乙酰丙酸(ALA)作为光动力试剂。我们通过分两个阶段执行的四个具体目标来实现这一点：我们首先调整和校准当前用于LMIC的临床PDT技术(AIMS 1和2 UH2阶段)，然后在LMIC现场(印度)进行验证研究，并为低成本PDT作为口腔癌症治疗的全球健康技术的长期可持续性制定业务计划(AIM 3和4 UH3阶段)。AIM 1将调整和校准现有的口腔癌PDT治疗和成像技术，使其成为低成本、电池供电的形式。Aim 2将在口腔癌临床前仓鼠模型中优化基于LED的ALA/PpIX PDT和成像。目的3将验证PDT治疗口腔癌和LMIC部位异型增生的临床表现。AIM 4将建立一个可持续的长期业务、传播和医疗培训计划。通过与印度阿里加尔穆斯林大学(AMU)贾瓦哈拉尔·尼赫鲁医院、太阳制药公司(总部设在印度的企业集团和ALA供应商)的子公司DUSA制药公司、马萨诸塞州的光学仪器设计公司物理科学公司(PSI)以及在全球提供PDT方面具有丰富经验的医生顾问的密切合作关系，这一设计特别针对印度背景。UH3阶段还将包括可持续的业务计划制定，并将评估纳入太阳能电池(不是当前应用的一部分)的长期目标，我们将就此向达特茅斯人道主义工程(DHE)寻求建议，该工程已投入大量资源研究新兴经济体的可持续性问题。这将由我们的一名调查人员提供便利，他是DHE的活跃校友。

DESCRIPTION (provided by applicant): Oral cancer represents over 30% of cancers reported in India, one of the highest oral cancer rates in the world, (attributed to the widespread popularity of chewing "gutka") and is the leading cause of cancer death among Indian men. The overall impact is increased morbidity, mortality and economic burden. This application aims to address the problem of oral cancer by using a low cost adaptation of photodynamic therapy (PDT), an active area of research in our group. The thrust of the study is to design a platform that can be used at sites without medical infrastructure and uses battery-powered light sources and smart phones along with d-aminolevulinic acid, (ALA) as the photodynamic agent. We achieve this in four specific aims executed in two phases: We initially adapt and calibrate current clinical PDT technologies for LMIC use (Aims 1and 2 UH2 phase), then, conduct a validation study at the LMIC site (India) and establish a business plan for long term sustainability of low cost PDT as a global health technology for oral cancer treatment (Aims 3 and 4 UH3 phase).Aim 1 will adapt and calibrate existing PDT treatment and imaging technologies for oral cancers to a low-cost, battery powered format. Aim 2 will optimize LED-based ALA/PpIX PDT and Imaging in pre-clinical hamster models of oral cancer. Aim 3 will validate clinical performance of PDT treatment of oral cancers and dysplasia at LMIC sites. Aim 4 will establish a sustainable long-term business, dissemination and healthcare training plan. The design is made particular to the Indian context by strong collaborative relationships with surgeons and therapists in at the Jawaharlal Nehru Hospital, Aligarh Muslim University (AMU), India, DUSA pharmaceuticals, a subsidiary of Sun Pharmaceuticals (an India-based conglomerate and suppliers of ALA), Physical Sciences Inc. (PSI) an optical instrument design Massachusetts company and physician consultants with extensive experience in the delivery of PDT globally. The UH3 phase will also include a sustainable business plan development and will evaluate the long-term goal of incorporating solar powered batteries (not part of the current application) for which we will reach out for advice to the Dartmouth Humanitarian Engineering (DHE) that has devoted significant resources to studying sustainability issues in emerging economies. This will be facilitated by one of our investigators who is an active alumnus of DHE.