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

CPSI Biotech是一家专门从事热消融治疗系统的医疗设备公司 各种癌症。CPSI开发的SCN系统现在处于原型形式，并已 在包括约翰·霍普金斯医学院在内的多个场所进行了动物试验。CPSI也 专门研究用于冷冻消融癌症的新型探头和导管。 SCN系统。这一阶段的SBIR应用建议开发一种新的设备和治疗方法 胰腺癌治疗方案(PACA)。CPSI已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)。该项目 包括开发(1)下一代双热消融(DTA)导管，该导管具有集成的 肿瘤间药物传递通道(QuadProbe)和SCN系统的必要重组 以及(2)确定将使差热分析更有效的热敏剂。根据第一阶段研究 研究小组将识别和测试目标化学分子的有效性 敏感剂与SCN和QuadProbe导管相结合，使擦除作用更强 有效治疗可切除和不可切除的PACA。此外，通过合并SELECT 现场定向药物治疗组合擦除方案将有助于解决与 针对未被发现的卫星癌人群的转移性疾病的管理。这个 该项目的目的是开发和表征下一代，灵活的，闭合的环，针 以导管为基础的内窥镜装置(QuadProbe)治疗PACA 侵入性的门诊手术。到目前为止收集到的原型装置和初步数据 支持这种方法的潜力。此阶段1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，增加 破坏PACA细胞；(3)开发药物/消融联合消融方案；(4)优化 在体外组织模型中进行擦除，以及(5)进行体内试验以验证和 技术/程序开发。第二阶段的研究将致力于优化四向 QuadProbe的功能(冷冻、加热、热敏仪喷射、活组织检查/组织抽吸 集合)以及与我们的约翰·霍普金斯大学的同事一起分析和调节 在接受了ERASE方案的患者中触发的免疫反应 结果是可以改善的。这个项目的成功完成将带来新技术 和治疗，以及提供数据支持建立 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的消融装置。该项目将利用并结合 CPSI、宾厄姆顿大学和约翰霍普金斯大学医学院的研究人员的专业知识 开发一种新的手术/敏化方法，以更有效地治疗PACA。一旦完成，这一点 该项目将为患有以下疾病的患者提供有效的、微创的治疗选择 PACA为改善患者生存和生活质量做出了贡献。

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.