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

摘要 为了确定间质光动力疗法(I-PDT)治疗实体瘤的疗效， 治疗医生需要能够为每个患者量身定做治疗方法。在临床的I-PDT期间，有一个 需要调整辐照度(光剂量率)和光通量(光剂量)以考虑患者特定的组织和 肿瘤光学特性，并解释在初始预处理后发生的纤维放置的变化 计划已生成。这可以通过新颖的、接近实时的计算软件DOSIETM来实现， 由SimPhotek，Inc.开发。Dosie的主要优点是：(I)它是专用的单包软件 用于计算I-PDT的瘤内光辐照度和通量的剂量度量的程序包；和(Ii)它包括 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 近乎实时的定位。为了证明Dosie可以有效地指导I-PDT，SimPhotek和RP提出了 对肺部实体恶性肿瘤患者进行第二期临床试验(IIa期) 涉及外源性肿瘤生长和相关的呼吸道压缩的呼吸道阻塞。拟议的审判将利用 使用经支气管针(TBN)引导光散射器的支气管内超声(EBUS) 纤维插入术用于I-PDT的瘤内照射。将采用的Dosie治疗计划系统 在这项试验中，计算肿瘤内的光通量和辐照度是至关重要的，这将影响I-PDT的肿瘤反应 在局部晚期癌症中。

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.