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.

PUBLIC HEALTH RELEVANCE: If successful, this study will benefit a large population of Indian men and women not only in terms of the overall quality of life but also by decreasing the number of workdays lost thus mitigating physical suffering and societal economic burden. This quest for lowering healthcare costs will also have potential significance in the U.S. where oral cancer is the 8th leading cause of cancer deaths amongst men. Finally, although the focus of this application is oral cancer in India, the findings would be applicable to other LMICs with high oral cancer burden and also could form the basis of low cost PDT for other cancers such as cancer of the uterine cervix, which remains a problem in emerging economy countries.