Patient tailored near real-time image-based treatment for interstitial PDT of Inoperable Cancer with Airway Obstruction - Phase IIa

为患者量身定制基于图像的近实时治疗，用于治疗气道阻塞且无法手术的癌症的间质 PDT - IIa 期

• 批准号: 10325471
• 负责人: Mary Potasek
• 金额: $ 105万
• 依托单位: SIMPHOTEK, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-11 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325471
• 关键词: 3-Dimensional; Address; Affect; Algorithms; Benchmarking; Bronchoscopes; Bronchoscopy; Clinic; Clinical Research; Code; Computer software; Data; Data Analyses; Development; Diffuse; Dose; Dose-Rate; Enrollment; Ensure; Fiber; Future; Goals; Image; Lasers; Light; Lighting; Locally Advanced Malignant Neoplasm; Location; Lung; Malignant Neoplasms; Measures; Methods; Monitor; Needles; Optics; Organ; PUVA Photochemotherapy; Patient-Focused Outcomes; Patients; Phase; Physicians; Porfimer Sodium; Positioning Attribute; Property; Pulmonary artery structure; Small Business Innovation Research Grant; Solid; Spectrum Analysis; Structure; System; Testing; Therapeutic; Therapeutic Studies; Time; Tissues; Translating; Treatment Efficacy; Treatment-Related Cancer; Tumor Tissue; Tumor Volume; Ultrasonography; Update; Variant; Visualization; Walking; Work; airway obstruction; base; cancer therapy; cost; effective therapy; image guided; improved; in vivo; individualized medicine; interstitial; novel; phase 1 study; preclinical study; prototype; real time monitoring; real-time images; response; success; tool; treatment optimization; treatment planning; tumor; tumor growth

Abstract To establish the efficacy of interstitial photodynamic therapy (I-PDT) for solid cancer treatments, the treating physician needs to be able to tailor the treatments to each patient. During I-PDT in the clinic, there is a need to adjust the irradiance (light dose rate) and fluence (light dose) to account for patient-specific tissue and tumor optical properties and to account for changes in fiber placements that occur after an initial pretreatment plan is generated. This can be accomplished with the novel, near real-time computational software, DOSIETM, developed by Simphotek, Inc. The DOSIE key advantages are: (i) it is a dedicated single-package software package for computing dose metrics of intratumoral light irradiance and fluence for I-PDT; and (ii) it includes a fast algorithm for updating the laser light settings according to optical properties of the tumor and actual fiber placement in near real-time. To demonstrate that DOSIE can effectively guide I-PDT, Simphotek and RP propose to conduct a pilot Phase II clinical study (Phase IIa) on patients with solid malignancies in the lung causing central airway obstruction involving extrinsic tumor growth and related airway compression. The proposed trial will utilize endobronchial ultrasound (EBUS) with a transbronchial needle (TBN) that will be used to guide optical diffuser fiber insertion for intratumoral illumination in I-PDT. The DOSIE treatment planning system that will be employed in this trial is vital to calculate the intratumoral fluence and irradiance, which will impact tumor response in I-PDT of the locally advanced cancers.

摘要 为了确定间质光动力疗法（I-PDT）用于实体癌治疗的功效， 治疗医师需要能够为每个患者定制治疗。在诊所的I-PDT期间， 需要调整辐照度（光剂量率）和通量（光剂量），以考虑患者特定组织， 肿瘤的光学性质，并考虑到在初始预处理后发生的纤维位置的变化 计划已生成。这可以通过新颖的近实时计算软件DOSIETM来实现， 由Simphotek，Inc. DOSIE的主要优点是：（i）它是一个专用的单包软件 用于计算I-PDT的肿瘤内光辐照度和通量的剂量度量的包;以及（ii）其包括 根据肿瘤和实际光纤的光学特性更新激光设置的快速算法 近实时定位。为了证明DOSIE可以有效地指导I-PDT，Simphotek和RP提出 在肺部实体恶性肿瘤患者中开展一项先导性II期临床研究（IIa期）， 涉及外源性肿瘤生长和相关气道压迫的气道阻塞。拟议的审判将利用 使用经支气管针（TBN）进行支气管内超声（EBUS），用于引导光学扩散器 I-PDT中用于肿瘤内照明的光纤插入。将采用的DOSIE治疗计划系统 在这项试验中，计算肿瘤内通量和辐照度至关重要，这将影响I-PDT中的肿瘤反应 局部晚期癌症。