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.

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其他NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 任务1：器械设计和开发 根据这项任务，科学与工程协会（SEA）及其分包商和顾问将开发一种新型的成像/光投影系统，以减轻与光动力疗法（PDT）相关的许多问题。该器械将包含Beckman激光研究所开发的调制成像技术（MI），该技术可在空间上映射病变部位患者的天然组织光学特性和光敏剂的摄取。然后，系统将能够使用SEA投影仪技术的基线信息，为患者定制激光治疗，以便提供最佳剂量。对于本任务，将确定这些过程的要求，设计、制造系统并将其提供给团队进行测试、评价，并最终部署到诊所对患者进行测试。 任务2：调制成像和PDT治疗开发 在这项任务下，该团队将开发一套治疗前组织表征测试和光敏剂测试，用于在PDT期间开发定制的激光治疗曲线。将在代表性体模上测试MI序列，以帮助验证和改善性能。组织属性图的可视化工具将是 制定并实施。将开发和测试组织光学特性用于定量评价光敏剂浓度的过程。临床测试开始后，该团队将评估所有组织光谱学和光敏剂图谱数据，以开发和改进方法，制定最佳激光剂量输送的治疗计划。的主要目的 该计划是开发实时剂量测定，而PDT治疗正在进行，以提供反馈给激光投影系统。收集数据和向激光投影仪反馈的时间将受到限制，因此在这项任务中，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的有效性。此外，我们将评估使用这些数据进行边缘检测以指导手术。 任务3：器械临床评价 在这项任务下，该团队将制定临床方案，并获得UC Irvine IRB和HRPO的批准。一旦获得批准，该设备将在60名活检证实患有基底细胞癌（BCC）的患者身上进行测试。对于第一轮测试，我们将使用开发的设备来测量影响PDT治疗过程的组织光学特性，例如光谱吸收和减少散射系数，氧合和脱氧血红蛋白，水和黑色素。第二轮将增加测试，通过荧光分析监测病变和正常皮肤的光敏剂摄取，最后一轮将重点关注根据患者的个人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价系统的性能。