Low Cost Carbon Dioxide-Based Cryoablation for Breast Cancer Treatment in Low Resource Settings

在资源匮乏的环境中进行低成本二氧化碳冷冻消融治疗乳腺癌

基本信息

批准号：
10324759
负责人：
Bailey Surtees
金额：
$ 40万
依托单位：
KUBANDA CRYOTHERAPY, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-01 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10324759
关键词：
Address Animal Model Area Argon Award Breast Cancer Model Breast Cancer Treatment Calorimetry Cancer Etiology Cancerous Canis familiaris Carbon Dioxide Cessation of life Client Clinic Clinical Trials Cold Therapy Complex Computers Cost Savings Cryosurgery Crystallization Development Devices Diagnosis Effectiveness Electricity Ensure Epithelial Family suidae Feedback Freezing Future Gases Geography Goals Health care facility Hospitalization Human Human Resources Ice Innovation Corps Institutional Review Boards Legal patent Liquid substance Liver Local Anesthetics Local anesthesia Low Prevalence Malignant Neoplasms Mammary Gland Parenchyma Mammary Neoplasms Mastectomy Monitor Necrosis Nitrogen Operating System Operative Surgical Procedures Outcome Outpatients Output Performance Phase Preparation Procedures Process Quality of life Rapid diagnostics Rattus Research Resources Risk Running Rural Safety Site Small Business Innovation Research Grant South African Survival Rate System Technology Testing Time Tissues Treatment outcome Tumor Tissue Ultrasonography Validation Woman Work base cancer therapy clinical application clinically relevant commercialization cost cryogenics design improved in vivo innovation low and middle-income countries malignant breast neoplasm molecular diagnostics necrotic tissue new technology novel phase 2 study portability procedure cost prototype safety testing standard care statistics subcutaneous success technology validation translation to humans treatment duration tumor underserved community wound

项目摘要

Summary The principal goal of this proposal is to demonstrate equivalence in efficacy of CO2- based percutaneous cryotherapy compared to commercial argon-based devices in order to improve the accessibility of a novel low-cost breast cancer treatment device for women in low-resource areas. Breast cancer is the leading cause of cancer death among women worldwide. Though more than 800,000 women are diagnosed each year in low-and-middle-income countries, standard treatment options are inaccessible and unaffordable in these low resource settings, and over half of these women will die within five years. Kubanda Cryotherapy offers a low-cost, non-resource-intensive breast cancer treatment that can be done in local clinics under local anesthetic and ultrasound guidance. Initial validation has been done on the current research prototype to demonstrate the effectiveness in cooling and necrosing cancer tissue in animal models including rats, swine and canines. This proposal aims to show that CO2-based percutaneous cryotherapy, although requiring a longer treatment period, is equally effective in necrosing cancerous masses compared to rapid freeze rate cryotherapy. To achieve this goal, we will perform cryotherapy using both rapid and slow freeze rate devices on twelve client-owned dogs with naturally developed mammary tumors. We will also quantitatively compare the cooling power of the two devices via calorimetry to obtain crucial understanding on key parameters and limitations related to procedure efficiency in order to continue further implementation of this technology. The main output of this project will be a robust and well- controlled cryotherapy device demonstrated to have equivalent efficacy to commercially available systems. Successful completion of this work will be an important step towards bridging the gap in breast cancer treatment in LMICs and offering women a chance at treatment. Upon completion of this proposal, we will apply for a Phase II award proposing to file IRB approval and begin clinical trials on the Kubanda cryotherapy device in order to bring low cost, affordable and effective breast cancer treatment to underserved communities worldwide.

概括该提案的主要目标是证明基于 CO2 的功效的等效性经皮冷冻疗法与商用氩气设备相比，以改善为资源匮乏地区的妇女提供新型低成本乳腺癌治疗设备。乳腺癌是全世界女性癌症死亡的主要原因。虽然超过中低收入国家每年有80万名女性被诊断出标准治疗在这些资源匮乏的环境中，选项是无法获得且负担不起的，并且其中一半以上女性将在五年内死亡。 Kubanda 冷冻疗法提供了一种低成本、非资源密集型的治疗方法乳腺癌治疗可在当地诊所通过局部麻醉和超声波进行指导。已对当前研究原型进行了初步验证，以证明在动物模型（包括大鼠、猪和犬齿。该提案旨在表明基于二氧化碳的经皮冷冻疗法，尽管需要治疗时间更长，与快速冷冻相比，对于坏死癌肿块同样有效率冷冻治疗。为了实现这一目标，我们将使用快速冷冻和慢速冷冻进行冷冻治疗对客户拥有的 12 只患有自然乳腺肿瘤的狗进行评估。我们还将通过量热法定量比较两种设备的冷却能力，以获得关键的了解与程序效率相关的关键参数和限制，以便继续该技术的进一步实施。该项目的主要成果将是一个强大且良好的受控冷冻治疗装置被证明具有与市售产品相当的功效系统。这项工作的成功完成将是缩小差距的重要一步。中低收入国家的乳腺癌治疗，并为女性提供治疗机会。完成此操作后提案，我们将申请 II 期资助，建议提交 IRB 批准并开始临床试验 Kubanda 冷冻治疗装置旨在带来低成本、实惠且有效的乳腺癌治疗为全世界服务不足的社区提供治疗。