LED LIGHT SOURCE FOR PHOTODYNAMIC THERAPY

用于光动力治疗的 LED 光源

• 批准号: 2096622
• 负责人: DANIEL R DOIRON
• 金额: $ 25万
• 依托单位: PDT SYSTEMS
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-09-18 至 1996-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2096622
• 关键词: biomedical equipment development; carcinoma; clinical biomedical equipment; clinical trials; human subject; human therapy evaluation; laboratory rat; light emission; neoplasm /cancer photoradiation therapy; nonhuman therapy evaluation; photosensitizing agents; radiation dosage; skin neoplasms; urinary tract neoplasms

Photodynamic Therapy, PDT, is presently undergoing extensive clinical trials for the diagnosis and treatment of cancer. Regulatory approval of first generation PDT drug, Photofrin, was obtained in Canada in 1993, and regulatory approval in Japan and the Netherlands is expected in 1994. Filing of an NDA for Photofrin for use in esophageal cancer is scheduled for early 1994. Clinical trials of a number of second generation PDT drugs are in progress or are about to begin. These include SnET2, BPD, NPe6, mTHPC and ZnPc. For skin treatment, a laser source is not necessary, and adds a significant cost and complexity to the procedure. The availability of a low cost Light Emitting Diode (LED) light source for surface illumination of skin lesions would allow treatments to be done more cost effectively and allow the therapy to be done in a physician's office or small clinic. Additionally an LED array would be a more practical light source for large area applications such as advanced psoriasis. It is the objective of the this project to further develop and test an LED light source for photodynamic therapy, suitable for clinical use. The LED system will include all exposure control and dosimetry functions necessary to effect a PDT treatment, with controls designed for the clinician. The system will employ easily interchangeable LED treatment heads, available in several sizes, to allow the clinician to treat a selected area of affected skin. The system will be extensively tested in a mouse tumor model to quantify the response relative to laser sources. During the latter part of the first year and during the second year of the study, the system will be incorporated into the SnET2 Phase-II clinical trials for the treatment of cutaneous cancers.

光动力疗法，PDT，目前正在进行广泛的临床 癌症的诊断和治疗试验。 监管批准 第一代PDT药物Photofrin于1993年在加拿大获得， 预计1994年将在日本和荷兰获得管理部门的批准。 Photofrin用于食管癌的NDA申请已按计划进行 1994年初。 一些第二代PDT的临床试验 药物正在进行或即将开始。 这些包括SnET 2，BPD， NPe6、mTHPC和ZnPc。 对于皮肤治疗，激光源不是 这是必要的，并且增加了手术的显著成本和复杂性。 低成本发光二极管（LED）光源的可用性 用于皮肤损伤的表面照明将允许治疗被 更经济有效地进行，并允许治疗在一个 医生的办公室或小诊所。 此外，LED阵列将 更实用的光源，用于大面积应用， 晚期牛皮癣 本项目的目标是进一步 开发和测试用于光动力疗法的LED光源， 供临床使用。 LED系统将包括所有曝光控制和 实现PDT治疗所需的剂量测定功能，有对照 专为临床医生设计。 该系统易于使用 可互换的LED治疗头，有多种尺寸可供选择， 临床医生治疗受影响皮肤的选定区域。 系统将 在小鼠肿瘤模型中进行广泛测试，以量化反应 相对于激光光源。 在第一年的后半段， 在研究的第二年，该系统将被纳入 SnET 2治疗皮肤病的II期临床试验 癌的