Saline Enhanced Radiofrequency Ablation for Liver Tumors

肝脏肿瘤的盐水增强射频消融

基本信息

批准号：
7248620
负责人：
MICHAEL G CURLEY
金额：
$ 103.04万
依托单位：
THERMEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
1996
资助国家：
美国
起止时间：
1996-09-01 至 2009-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7248620
关键词：
Ablation Alternative Therapies Caliber Cancer Center Clinical Clinical Trials Colorectal Cancer Complication Computer software Computers Depth Development Diagnosis Electrodes Electromagnetics Ensure Excision Family suidae Frequencies Health Heating Hepatitis C Incidence Incidence Industry Injection of therapeutic agent Lesion Life Expectancy Liver Liver neoplasms Malignant neoplasm of liver Medical Medical Device Medical center Modeling Multi-Institutional Clinical Trial Needles Neoplasm Metastasis Operative Surgical Procedures Patients Phase Primary carcinoma of the liver cells Procedures Pump Radiofrequency Interstitial Ablation Resected Safety Saline Standards of Weights and Measures Sterility Sterilization for infection control Syringes System Techniques Testing Texas Time Tissues United States United States Food and Drug Administration Universities Validation X-Ray Computed Tomography biomaterial compatibility design extracellular improved in vivo radiofrequency tumor

项目摘要

DESCRIPTION (provided by applicant): Liver cancer is a significant and increasing health concern. In the United States, there will be over 72,500 cases of colorectal cancer metastasized to the liver. Hepatocellular carcinoma (HCC) is also an increasing concern in the United States, primarily due to a rise in hepatitis C. The incidence of HCC in the United States has doubled to 17,550 cases over the last decade, and it is expected to double again over the next ten years. The vast majority of these patients will die within 5 years. The current standard for treating liver cancer is surgical resection, but only about 20% of patients are eligible for this procedure. Percutaneous radiofrequency ablation is one alternative therapy. In this therapy, a small electrode is inserted into the tumor and a high-power, high frequency electrical current heats the tumor. This therapy is a particularly attractive alternative to resection because it is inexpensive and it has a low incidence of complication. However, this therapy is only effective on small tumors-it is ineffective when treating tumors larger than 3-4 cm in diameter. A system capable of treating large tumors is critically needed since half of patients have tumors larger than 3 cm at initial diagnosis, and these larger tumors decrease life expectancy. We propose to complete the development of our saline-enhanced radiofrequency (SERF) ablation system capable of treating large liver tumors. Our system uses radiofrequency heating of tissue with simultaneous injection of hot saline through the electrode and into the tissue. The extracellular flow of saline convects the thermal energy deeper into the tissue to treat larger volumes than previously possible. Our technique has created 8 cm diameter thermal lesions in vivo. These treatment volumes are 20 times as large as those created with conventional RF electrodes. We will complete the design of our therapy system and needle and validate that it complies with medical electrical safety standards (EN60601-1), biocompatibility (ISO-10993), and validate the sterilization to a sterility assurance level (SAL) of 10(-6). We will then carry out a multi-center clinical trial at the MD Anderson Cancer Center, the University of Louisville, the University of Cincinnati and the Southwestern Medical Center. Upon completion of the clinical trial we will file and obtain 510(k) clearance to sell SERF ablation systems in the United States.

描述（由申请人提供）：肝癌是一个重要且日益严重的健康问题。在美国，将有超过 72,500 例结直肠癌转移至肝脏。肝细胞癌 (HCC) 在美国也日益受到关注，这主要是由于丙型肝炎的增加。过去 10 年，美国 HCC 的发病率翻了一番，达到 17,550 例，预计 2020 年将再翻一番。未来十年。这些患者绝大多数将在5年内死亡。目前治疗肝癌的标准是手术切除，但只有约20%的患者符合手术切除条件。经皮射频消融是一种替代疗法。在这种疗法中，将一个小电极插入肿瘤中，然后用高功率高频电流加热肿瘤。这种疗法是切除术的一种特别有吸引力的替代疗法，因为它便宜且并发症发生率低。然而，这种疗法只对小肿瘤有效——当治疗直径大于3-4厘米的肿瘤时就无效了。迫切需要一种能够治疗大型肿瘤的系统，因为一半患者在初次诊断时肿瘤大于 3 厘米，而这些较大的肿瘤会降低预期寿命。我们建议完成能够治疗大型肝脏肿瘤的盐水增强射频（SERF）消融系统的开发。我们的系统使用射频加热组织，同时通过电极将热盐水注射到组织中。盐水的细胞外流将热能对流到组织更深处，以治疗比以前更大的体积。我们的技术在体内创造了直径 8 厘米的热损伤。这些治疗体积是使用传统射频电极产生的治疗体积的 20 倍。我们将完成治疗系统和针头的设计，并验证其符合医疗电气安全标准 (EN60601-1)、生物相容性 (ISO-10993)，并验证灭菌是否达到 10(- 6).然后我们将在MD安德森癌症中心、路易斯维尔大学、辛辛那提大学和西南医学中心进行多中心临床试验。临床试验完成后，我们将提交并获得 510(k) 许可，在美国销售 SERF 消融系统。