ERASE - A new dual thermal ablation/SCN device system for treating pancreatic cancer

CPSI Biotech是一家医疗器械公司，专门从事热消融系统治疗 各种癌症。由CPSI开发的SCN系统目前处于原型形式， 在包括约翰霍普金斯医学院在内的各种场所进行了动物试验。CPSI还 专门从事设计用于癌症冷冻消融的新型探针和导管， SCN系统。本SBIR申请的第1阶段旨在开发一种新的器械和治疗方法 治疗胰腺癌（PaCa）的方案。CPSI将这种新方法命名为ERASE （基于内窥镜的联合消融和致敏治疗程序）。项目 包括开发（1）下一代双热消融（DTA）导管， 肿瘤间药物递送通道（QuadProbe）和SCN系统的必要重新设计， 以及（2）识别将使DTA更有效的热敏化剂。I期研究 研究小组将确定和测试目标化学分子的有效性， 致敏剂与SCN和QuadProbe导管结合使用， 有效治疗可切除和不可切除PaCa。此外，通过选择 位点定向药物治疗组合ERASE方案将有助于解决 针对未被发现的卫星癌症人群的转移性疾病的管理。的 本项目的目的是开发和表征下一代柔性闭环针头 用于治疗PaCa的基于导管的内窥镜器械（QuadProbe）， 侵入性门诊手术。原型装置和迄今为止收集的初步数据有力地证明了这一点。 支持这种方法的潜力。第一阶段提案的主要目标是（1）开发 QuadProbe DTA导管，（2）识别一系列药物，当与DTA一起使用时， 破坏PaCa细胞，（3）开发组合药物/消融ERASE方案，（4）优化 在离体组织模型中ERASE，以及（5）进行初步体内研究以进行验证， 技术/程序开发。第2阶段研究将致力于优化四向 QuadProbe的功能（冷冻、加热、热感应器弹出、活检/组织抽吸 收集）以及与我们的约翰霍普金斯同事分析和调节 在接受ERASE方案的患者中触发免疫应答， 结果可以得到改善。这个项目的成功完成将导致新的技术 和治疗PaCa的管理，以及提供数据，以支持建立 建议的最佳临床应用所需的热剂量参数，以及 其他用于治疗PaCa的消融器械。本项目将利用并联合收割机 来自CPSI、宾厄姆顿大学和约翰霍普金斯医学院的研究人员的专业知识 开发一种新的手术/致敏剂方法，以更有效地治疗PaCa。一旦完成， 该项目将为患有以下疾病的个人提供有效的微创治疗选择： PaCa有助于改善患者生存率和生活质量。

CPSI Biotech is a medical device company that specializes in thermal ablation systems for treating a variety of cancers. The SCN systems developed by CPSI are now in prototype form and have been animal tested at a variety of venues including Johns Hopkins School of Medicine. CPSI also specializes in novel probes and catheters designed for the cryoablation of cancers for use with the SCN system. This Phase 1 SBIR application proposes to develop a new device and treatment regime for treating pancreatic cancer (PaCa). CPSI has named this new approach ERASE (Endoscopic-based combinatoRial Ablative and Sensitization therapeutic procedurE). The project includes the development of a (1) next gen dual thermal ablation (DTA) catheter with an integrated intertumoral drug delivery channel (QuadProbe) and requisite re-engineering of the SCN system as well as (2) identifying thermal sensitizers that will make DTA more effective. Under Phase 1 studies the investigational team will identify and test the effectiveness of the targeted chemical molecular sensitizers in conjunction with the SCN and QuadProbe catheter to develop ERASE to more effectively treat resectable and nonresectable PaCa. Further, through the incorporation of select site directed drug therapy the combinatorial ERASE protocol will help address the challenges with the management of metastatic disease targeting undetected satellite cancer populations. The intent of this project is to develop and characterize a next generation, flexible, closed loop, needle catheter-based endoscopic device (QuadProbe) for the treatment of PaCa employing a minimally invasive outpatient procedure. The prototype device and preliminary data collected to date strongly support the potential of this approach. The major goals of this Phase 1 proposal are to (1) develop the QuadProbe DTA catheter, (2) identify a series of drugs that when used with DTA increase the destruction of PaCa cells, (3) develop the combinatorial drug/ablation ERASE protocol, (4) optimize ERASE in an ex vivo tissue model, and (5) conduct a pilot in vivo study for validation and technology/procedural development. Phase 2 studies will be dedicated to optimizing the four-way function of the QuadProbe (freezing, heat, thermal sentizer ejection, biopsy/tissue aspirate collection) as well as working with our Johns Hopkins colleagues analyzing and modulating the immune response triggered in patients who have undergone the ERASE protocol so that patient outcome can be improved. The successful completion of this project will lead to new technology and therapy for the management of PaCa as well as provide data in support of establishing the thermal dose parameters necessary for optimal clinical application of the proposed, as well as other, ablation devices for the treatment of PaCa. This project will leverage and combine the expertise of researchers from CPSI, Binghamton University, and Johns Hopkins School of Medicine to develop a new surgical/sensitizer approach to more effectively treat PaCa. Once completed, this project will provide for an effective, minimally invasive treatment option for individuals suffering from PaCa contributing to efforts for improving patient survival and quality of life.