Ultrasound-guided Interventional Cryoneedle System for Enhanced Tumor Chemoablati

超声引导介入冷冻针系统增强肿瘤化疗

• 批准号: 7749316
• 负责人: Patrick Jean LePivert
• 金额: $ 15.18万
• 依托单位: NUVUE THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-14 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7749316
• 关键词: Address; Adherence; Adverse effects; American Cancer Society; Anatomy; Animals; Cancer Patient; Catheters; Chemical Agents; Clinical; Color; Computer software; Computers; Critical Care; Deposition; Development; Devices; Dose; Drug Delivery Systems; Evaluation; Fresh Tissue; Government; Hybrids; Image; Imagery; In Vitro; Injection of therapeutic agent; Lesion; Life; Liquid substance; Liver; Malignant Neoplasms; Methodology; Modification; Monitor; Movement; Needles; Operative Surgical Procedures; Outcome; Performance; Persons; Phase; Polymers; Positioning Attribute; Research; Series; Site; Solid Neoplasm; System; Techniques; Testing; Therapeutic; Time; Tissues; Toxic effect; Treatment-Related Cancer; Ultrasonography; Work; alternative treatment; base; chemotherapeutic agent; cytotoxic; design; fluid flow; improved; in vivo; innovation; interest; interstitial; laptop; minimally invasive; palliative; pre-clinical; public health relevance; reconstruction; research study; response; sensor; software development; tissue phantom; tissue trauma; tumor; tumor xenograft

DESCRIPTION (provided by applicant): Chemoablation consists of applying a cytotoxic chemical agent via a needle (or needle-like system) directly to a target lesion in order to destroy it. This approach has gained clinical interest because it is a minimally invasive alternative treatment for tumors and it has the potential to minimize tissue trauma, increase local efficacy, and decrease side effects and systemic toxicity, but several obstacles related to the existing delivery techniques hinder its more widespread use. Thus, a methodology must be developed to reliably inject the full dose of active agent(s) into a lesion, to monitor and control the distribution of the agent(s) within the target in real-time, and to assess the extent of damage following the chemo-injection. A hybrid cooling and deployable injection needle system incorporating thermal sensors will be designed and combined with a handheld vibratory mechanism. [Note: The following contains proprietary/privileged information that Critical Care Innovations, Inc. requests not be released to persons outside the Government, except for purposes of review and evaluation]. The device will be used to test the hypothesis that a cooling probe/injection needle assembly combined with an existing vibratory locating device will allow enhanced visualization of both the positioning of the needle within the targeted tumor as well as the delivery of a chemotherapeutic agent to the tumor without backflow. Furthermore, control of the coolant within the probe will differentially influence the adherence of tissue to the needle system as well as the distribution and retention of the chemotherapeutic agent throughout the surrounding tissue. The device will be integrated into a laptop-based ultrasound imager equipped with color-flow Doppler capability, and the necessary software will be developed to allow for computational reconstruction of the thermal fields around the device tip where drug delivery will occur. A series of experiments in phantoms and in vitro tissues will be conducted to evaluate the whole system's performance in imaging, thermal analysis, and controlling the agent(s) injection and distribution. Once fully developed, the integrated ultrasound-guided, cryo-assisted injection system (known as CryoCool") will allow for an overlay of the computed thermal fields with anatomic images, ultimately improving real-time chemoablation of tumors. Such a new device will address existing outcome variability due to operators' inexperience, inaccurate ultrasonic image guidance, and unreliability in providing safe and predictable therapeutic dose deposition. PUBLIC HEALTH RELEVANCE: Between 30 and 35% of solid tumors are inoperable, which represents 300,000 to 350,000 of the approximate 1 million new cancer patients a year (according to the 2004 American Cancer Society, Inc. Surveillance Research). Interventional techniques are currently explored as alternatives to surgery in the palliative or curative settings; chemoablation is such a technique and consists of applying a cytotoxic chemical agent via a needle directly to a target lesion in order to destroy it. Chemoablation is of interest because it has the potential to minimize tissue trauma, increase local efficacy, and decrease side effects and systemic toxicity, but the development of new chemoablative devices is imperative in order to exploit the full potential of this technique.

描述（由申请人提供）： 化学消融术包括通过针施加细胞毒性化学剂这种方法已经获得了临床兴趣，因为它是用于肿瘤的微创替代治疗，并且它具有使组织创伤最小化、增加局部功效和降低副作用和全身毒性的潜力，但与现有的递送技术有关的若干障碍阻碍了其更广泛的使用。因此，必须开发一种方法，以可靠地将全剂量的活性剂注射到病变中，实时监测和控制活性剂在靶标内的分布，并评估化学注射后的损伤程度。将设计一种结合热传感器的混合冷却和可展开注射针系统，并将其与手持式振动机构相结合。[Note：以下内容包含Critical Care Innovations，Inc.除非为了审查和评估的目的，否则不得向政府以外的人发布请求]。该装置将用于测试以下假设：冷却探针/注射针组件与现有的振动定位装置组合将允许增强针在靶向肿瘤内的定位以及将化疗剂输送到肿瘤而不回流的可视化。此外，对探针内的冷却剂的控制将不同地影响组织对针系统的粘附以及化疗剂在整个周围组织中的分布和保留。该设备将被集成到一个基于笔记本电脑的超声成像仪配备彩色血流多普勒功能，并将开发必要的软件，以允许计算重建周围的药物输送将发生的设备尖端的热场。将在体模和体外组织中进行一系列实验，以评估整个系统在成像、热分析和控制药剂注射和分布方面的性能。一旦完全开发，集成的超声引导，冷冻辅助注射系统（称为CryoCool）将允许计算的热场与解剖图像的叠加，最终改善肿瘤的实时化学消融。这种新装置将解决由于操作者缺乏经验、超声图像引导不准确以及提供安全和可预测的治疗剂量沉积不可靠而导致的现有结果可变性。公共卫生相关性：30%至35%的实体瘤是不可手术的，这代表了每年约100万新癌症患者中的300，000至350，000人（根据2004年美国癌症协会，Inc.监督研究）。目前正在探讨在姑息或治疗情况下，将介入技术作为外科手术的替代方法;化学消融术就是这样一种技术，包括通过针将细胞毒性化学剂直接施加到靶病变以破坏它。化学消融术是令人感兴趣的，因为它具有使组织创伤最小化、增加局部功效、并降低副作用和全身毒性的潜力，但是为了开发这种技术的全部潜力，开发新的化学消融装置是必要的。