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

• 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
• 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

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.

摘要 这项提议的主要目标是证明在二氧化碳基础上的同等效力 将经皮冷冻治疗与商用的基于氩的设备进行比较，以改善 低资源地区妇女使用新型低成本乳腺癌治疗设备的可获得性。 乳腺癌是全球女性癌症死亡的主要原因。尽管不仅仅是 在低收入和中等收入国家，每年有80万妇女被确诊，接受标准治疗 在这些低资源环境中，选项是不可访问和负担不起的，其中超过一半的选项 女性将在五年内死亡。库班达冷冻疗法提供了一种低成本、非资源密集型 可以在当地诊所通过局部麻醉和超声波进行的乳腺癌治疗 指导。已经对当前的研究原型进行了初步验证，以演示 冷却和坏死癌组织的动物模型包括大鼠，猪和 犬科动物。这项建议旨在表明，基于二氧化碳的经皮冷冻疗法，尽管需要 与快速冷冻相比，更长的治疗期对坏死的癌性肿块同样有效 速冻疗法。为了达到这个目标，我们将同时使用快速冷冻和缓慢冷冻进行冷冻治疗。 在12只患有自然发展的乳腺肿瘤的客户拥有的狗身上对设备进行评级。我们还将 通过量热法定量比较两种设备的冷却功率，以获得关键的 了解与程序效率有关的关键参数和限制，以便继续 这项技术的进一步实施。该项目的主要产出将是一个强大和良好的- 受控冷冻治疗设备被证明与商业上可获得的效果相同 系统。这项工作的圆满完成将是弥合 在LMICs中治疗乳腺癌，并为妇女提供治疗的机会。在完成此操作后 建议，我们将申请第二阶段奖励，建议提交IRB批准并开始临床试验 库班达冷冻治疗仪旨在为乳腺癌带来低成本、实惠和有效的 向世界各地服务不足的社区提供治疗。