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

图像引导口腔光动力治疗 (PDT) 的低成本实现技术

• 批准号: 9339767
• 负责人: Jonathan P Celli
• 金额: $ 98.98万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-19 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9339767
• 关键词: Acacia; Accounting; Address; Aminolevulinic Acid; Area; Asia; Benchmarking; Biological Models; Biopsy; Businesses; Calibration; Cancer Burden; Cancer Etiology; Cancer Patient; Carcinogen exposure; Caring; Case Study; Cellular Phone; Cessation of life; Charge; Cheek structure; Clinical; Clinical Research; Consultations; Contrast Media; Country; Coupled; Data; Deglutition; Dental; Development Plans; Devices; Disease; Early Intervention; Economic Burden; Education; Engineering; Fiber; Goals; Guidelines; Hamsters; Health; Health Care Costs; Health Services Accessibility; Health Technology; Healthcare; Histology; Hospitals; Human; Image; Imaging technology; Implant; India; International; Lesion; Light; Location; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Massachusetts; Mastication; Medical; Modality; Modeling; Morbidity - disease rate; Muslim population group; Necrosis; Nuts; Operative Surgical Procedures; Optical Instrument; Optics; Oral; Oral cavity; Output; PUVA Photochemotherapy; Pakistan; Patients; Performance; Pharmacologic Substance; Phase; Physical Sufferings; Physicians; Population; Provider; Quality of life; Radiation therapy; Reporting; Research; Research Infrastructure; Research Personnel; Resources; Rural; Series; Shapes; Site; Source; Sri Lanka; Staging; Surgeon; Technology; The Sun; Tobacco; Trainers Training; Training; United States National Institutes of Health; Universities; Woman; Work; base; cancer imaging; cancer therapy; clinical research site; cost; density; design; dimethylbenzanthracene; engineering design; experience; fluorescence imaging; follow-up; forging; global health; image guided; in vivo; industry partner; instrumentation; low and middle-income countries; malignant mouth neoplasm; medical schools; men; mortality; novel therapeutics; oncology; oral dysplasia; oral lesion; physical science; pre-clinical; research study; rural area; screening; tissue phantom; treatment response; tumor; validation studies

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.

描述（由申请人提供）：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“gutka”的广泛流行），是印度男性癌症死亡的主要原因。总的影响是发病率、死亡率和经济负担增加。本应用程序旨在通过使用低成本的光动力疗法（PDT）来解决口腔癌的问题，这是我们小组的一个活跃的研究领域。这项研究的重点是设计一个平台，可以在没有医疗基础设施的地方使用，并使用电池供电的光源和智能手机以及d-氨基乙酰丙酸（ALA）作为光动力剂。我们通过分两个阶段执行的四个具体目标来实现这一目标：我们首先调整和校准LMIC使用的当前临床PDT技术（目标1和2 UH2阶段），然后在LMIC站点（印度）进行验证研究，并建立长期可持续性低成本PDT作为口腔癌治疗的全球健康技术的商业计划（目标3和4 UH3阶段）。Aim 1将适应和校准现有的口腔癌PDT治疗和成像技术，以低成本，电池供电的形式。目的2将优化基于led的ALA/PpIX PDT和口腔癌仓鼠临床前模型的成像。目的3将验证PDT治疗口腔癌和LMIC部位发育不良的临床表现。目标4将制定可持续的长期业务、传播和保健培训计划。通过与印度贾瓦哈拉尔尼赫鲁医院、阿里加尔穆斯林大学（AMU）、太阳制药公司（一家总部位于印度的企业集团和ALA供应商）的子公司DUSA制药公司、马萨诸塞州光学仪器设计公司物理科学公司（PSI）以及在全球范围内提供PDT的丰富经验的医师顾问的密切合作，该设计特别适合印度的环境。UH3阶段还将包括可持续商业计划的制定，并将评估纳入太阳能电池的长期目标（不是当前应用的一部分），为此我们将向达特茅斯人道主义工程学院（DHE）寻求建议，该学院已投入大量资源研究新兴经济体的可持续性问题。这将由我们的一位调查人员协助，他是DHE的活跃校友。