SEATREAT CANCER TECHNOLOGY / SEATREAT PHOTODYNAMIC THERAPY (PDT)

SEATREAT 癌症技术 / SEATREAT 光动力疗法 (PDT)

• 批准号: 8362668
• 负责人: ANTHONY J DURKIN
• 金额: $ 0.51万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8362668
• 关键词: Basal cell carcinoma; Biopsy; Biotechnology; Characteristics; Clinic; Clinical Protocols; Data; Detection; Device Approval; Device Designs; Device or Instrument Development; Devices; Dose; Effectiveness; Engineering; Feedback; Fluorescence; Funding; Grant; Image; Imagery; Imaging Techniques; Individual; Institutes; Institutional Review Boards; Lasers; Lesion; Light; Malignant Neoplasms; Maps; Measures; Melanins; Methods; Monitor; National Center for Research Resources; Operative Surgical Procedures; Optics; Oxyhemoglobin; Patients; Performance; Photochemotherapy; Photosensitizing Agents; Principal Investigator; Process; Property; Quantitative Evaluations; Research; Research Infrastructure; Resources; Science; Site; Skin; Source; Spectrum Analysis; System; Technology; Testing; Time; Tissues; United States National Institutes of Health; Water; absorption; base; cost; deoxyhemoglobin; design; dosimetry; evaluation/testing; improved; novel; performance tests; programs; research clinical testing; skin lesion; therapy development; tool; treatment planning; uptake

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. Task 1: Device Design and Development Under this Task, Science & Engineering Associates (SEA) and its subcontractors and consultants, will develop a novel imaging/light projection system that will mitigate many of the issues associated with photodynamic therapy (PDT). The device will incorporate a Modulating Imaging technique (MI), developed at the Beckman Laser Institute, that spatially maps the native tissue optical properties of the patient at the lesion site and the uptake of photosensitizer. The system will then be able to use this baseline information with SEA projector technology to customize the laser treatment for the patient so that the optimum dose is provided. For this Task, the requirements for these processes will be identified, the system designed, fabricated and provided to the team for test, evaluation and eventual deployment in the clinic for testing on patients. Task 2: Modulated Imaging & PDT Treatment Development Under this task, the team will develop the suite of pre-treatment tissue characterization tests and photosensitizer tests that will be used to develop a customized laser treatment profile during PDT. The MI sequences will be tested on representative phantoms to help verify and improve performance. Visualization tools for the tissue property maps will be developed and implemented. The process by which the tissue optical properties are used to enable the quantitative evaluation of photosensitizer concentration will be developed and tested. After initiation of the clinical testing, the team will evaluate all of the data tissue spectroscopy and photosensitizer maps to develop and improve the methods to produce a treatment plan for optimum laser dose delivery. A primary objective of the program is to develop real-time dosimetry while the PDT treatment is being conducted to provide feedback to the laser projection system. The timeframe to collect data and feedback to the laser projector will be limited, so under this task, we will investigate the most effective tests that can be conducted during the treatment to improve PDT effectiveness. In addition, we will evaluate the use of this data for margin detection for surgical guidance. Task 3: Clinical Evaluation of Device Under this task the team will develop the clinical protocol and obtain approval of the UC Irvine IRB and HRPO. Upon approval the device will be tested on 60 patients that have biopsy-confirmed basal cell carcinoma (BCC). For the first round of testing, we will use the device developed to measure tissue optical properties that effect the PDT treatment process, such as spectral absorption and reduced scattering coefficients, oxy- and deoxyhemoglobin, water and melanin. The second round will add testing to monitor the photosensitizer uptake into the lesion and normal skin via fluorescence analysis, and the last round will focus on the implementation of customized treatment for the patient based upon their individual skin and lesion characteristics. For the last round of testing, the performance of the system will be evaluated by performing surgery one month after PDT.

该副本是利用资源的众多研究子项目之一 由NIH/NCRR资助的中心赠款提供。对该子弹的主要支持 而且，副投影的主要研究员可能是其他来源提供的 包括其他NIH来源。 列出的总费用可能 代表subproject使用的中心基础架构的估计量， NCRR赠款不直接向子弹或副本人员提供的直接资金。 任务1：设备设计和开发 在此任务下，科学与工程伙伴（SEA）及其分包商和顾问将开发出一种新颖的成像/光投影系统，该系统将减轻与光动力疗法（PDT）相关的许多问题。该设备将在贝克曼激光学院开发的调节成像技术（MI），该技术在病变部位上绘制患者的天然组织光学特性和对光敏剂的吸收。然后，该系统将能够使用SEA投影仪技术使用此基线信息来定制患者的激光治疗，以便提供最佳剂量。对于此任务，将确定这些过程的要求，将系统设计，制造和提供给团队，以进行测试，评估和最终在诊所中进行测试，以便对患者进行测试。 任务2：调制成像和PDT治疗开发 在此任务下，团队将开发预处理组织表征测试和光敏剂测试的套件，该测试将用于在PDT期间开发自定义的激光治疗概况。 MI序列将在代表性幻象上进行测试，以帮助验证和提高性能。组织特性图的可视化工具将是 开发和实施。将使用组织光学特性来实现光敏剂浓度的定量评估的过程。在开始临床测试后，该团队将评估所有数据组织光谱和光敏剂图，以开发和改进制定治疗计划以实现最佳激光剂量递送的方法。一个主要目标 程序是在进行PDT处理时开发实时剂量测定法以提供激光投影系统的反馈。收集数据和反馈对激光投影仪的时间范围将受到限制，因此在此任务下，我们将研究在治疗期间可以进行的最有效的测试，以提高PDT效果。此外，我们将评估该数据的使用余量检测用于手术指导。 任务3：设备的临床评估 在此任务下，团队将制定临床方案，并获得UC Irvine IRB和HRPO的批准。批准后，将对60名具有活检确认基底细胞癌（BCC）的患者进行测试。对于第一轮测试，我们将使用开发的设备来测量影响PDT处理过程的组织光学特性，例如光谱吸收以及散射系数减少，氧和脱氧血红蛋白，水和黑色素。第二轮将增加测试，以通过荧光分析监测病变和正常皮肤的光敏剂摄取，最后一轮将集中于根据患者的单个皮肤和病变特征为患者实施定制治疗。对于最后一轮测试，将通过在PDT后一个月进行手术来评估系统的性能。