Integration of non-invasive deep tissue microwave thermometry in the VectRx hyperthermia device in a transgenic liver tumor pig model

在转基因肝肿瘤猪模型中将非侵入性深部组织微波测温技术集成到 VectRx 热疗装置中

• 批准号: 10697183
• 负责人: Pierre Floriano
• 金额: $ 40万
• 依托单位: NEOTHERMA ONCOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10697183
• 关键词: Abdomen; Acute; Address; Adjuvant Therapy; Adopted; Adoption; Affect; Animals; Characteristics; Chemotherapy and/or radiation; Chicago; Cities; Clinical; Clinical Services; Clinical Trials; Collaborations; Colorado; Data; Development; Devices; Diagnosis; Disease; Drug Delivery Systems; Effectiveness; Electronics; Elements; Eligibility Determination; Ensure; Environment; FDA approved; Family suidae; Fat necrosis; Feasibility Studies; Feedback; Fiber Optics; Frequencies; Future; Geometry; Goals; Heating; Human; Human Resources; Hyperthermia; Illinois; Implant; Kansas; Kidney; Liver; Liver neoplasms; Location; Longitudinal Studies; Magnetic Resonance; Magnetic Resonance Imaging; Malignant neoplasm of pancreas; Marketing; Maryland; Measurement; Measures; Mediating; Medical Device; Medical center; Modeling; Modification; Monitor; Newly Diagnosed; Oncology; Oncopig; Operative Surgical Procedures; Organ; Pancreas; Pathway interactions; Patient-Focused Outcomes; Patients; Pattern; Performance; Phase; Primary carcinoma of the liver cells; Radiation; Radiation therapy; Radiation-Sensitizing Agents; Reporting; Research Personnel; Resolution; Safety; Series; Services; Skin; Small Business Innovation Research Grant; Solid Neoplasm; Spleen; Structure; Survival Rate; System; Techniques; Technology; Temperature; Testing; Thermometers; Thermometry; Time; Tissues; Transgenic Organisms; Translations; United States; Universities; Work; biomaterial compatibility; cost; curative treatments; design; dielectric property; experimental study; first-in-human; improved; in silico; innovation; invention; microwave electromagnetic radiation; novel; operation; optical fiber; pancreatic cancer model; pancreatic cancer patients; perfusion imaging; porcine model; preclinical study; prototype; radiofrequency hyperthermia; risk mitigation; sensor; skin burn; standard of care; success; tool; tumor; ultrasound

Project Summary/Abstract NeoTherma Oncology (NTO/www.neothermaoncology.com) has developed a novel non-invasive medical device that delivers mild hyperthermia (HT) loco-regionally as adjuvant therapy to standard of care treatment of abdominal deep-seated tumors. The VectRx™ device, designated “Breakthrough” by the FDA, has demonstrated its ability to safely heat abdominal organs (pancreas, liver, kidney, spleen) in pre-clinical studies in healthy swine. FDA approved an investigational device exemption for VectRx on the basis of these data and the lack of a validated large animal tumor model for pancreatic cancer. NTO has initiated a First in Human early feasibility study (EFS) study at the University of Maryland Medical Center to collect initial safety and performance data in pancreatic cancer patients. In parallel to the EFS, NTO will collaborate with University of Colorado-Boulder researchers who have developed a microwave thermometer (MT) that could be utilized to non-invasively measure temperatures in deep tissue. This development is based on the ability to detect the black body radiation proportional to temperature that is emitted at different tissue depths from skin to deep organ. Successful integration of the MTs will effectively improve the clinical utility of VectRx. This will address challenges posed by the limited availability, access, high cost, logistical concerns and reliance on specialized personnel, as is the case with magnetic resonance thermometry. A series of MTs and a radiometer will be designed, fabricated, and integrated into VectRx with potential VectRx coil adjustments to 1) achieve compatible designs of active and passive MTs with operation within VectRx (on and off); 2) manage any potential heating of the MTs, coil detuning, E-field and H-field pattern integrity during VectRx operation. Following co-development and optimization, the MTs’s performance will be established in a hepatocellular carcinoma (HCC) Oncopig model with an accuracy goal of 1.5°C. HCC is a disease with low survival rates and only a small fraction (15%) of newly diagnosed patients are eligible for curative treatments due to late diagnosis. The model is relevant to NTO’s indication pipeline of deep-seated abdominal tumors, and NTO has previously completed installation of the VectRx device and performed preliminary work in 3 HCC Oncopigs with the veterinary team at the University of Illinois to optimize ultrasound- guided surgical placement of fiberoptic probes that will be used to correlate temperatures measured by the MTs. Despite the known benefits of mild HT, it has not been widely adopted in the US because of the technical limitations of current technologies to address deep, hard to heat tumors and the lack of thermometry. In this Phase I project, we will demonstrate that these critical deficiencies can be overcome through integration of novel microwave-based temperature techniques with VectRx, providing an innovative demonstration of advanced temperature monitoring of HT in deep tissue in a large animal tumor model.

项目概要/摘要 NeoTherma Oncology (NTO/www.neothermaoncology.com) 开发了一种新型非侵入性医疗设备 局部局部温和热疗（HT）作为标准护理治疗的辅助治疗 腹部深部肿瘤的 VectRx™ 设备被 FDA 指定为“突破性”设备。 其在临床前研究中安全加热腹部器官（胰腺、肝脏、肾脏、脾脏）的能力 FDA 根据这些数据批准了 VectRx 的研究设备豁免 由于缺乏经过验证的胰腺癌大型动物肿瘤模型，NTO 在人类早期开展了首次研究。 马里兰大学医学中心的可行性研究 (EFS) 研究收集初步安全性和性能 胰腺癌患者的数据。 在 EFS 的同时，NTO 将与科罗拉多大学博尔德分校的研究人员合作，他们开发了 微波温度计（MT）可用于非侵入性测量深层组织的温度。 这一发展基于检测与温度成比例的黑体辐射的能力，即 MT 的成功整合将有效地发射到从皮肤到深层器官的不同组织深度。 提高 VectRx 的临床效用，这将解决有限的可用性、可及性和高可用性带来的挑战。 成本、后勤问题以及对专业人员的依赖，就像磁共振的情况一样 一系列 MT 和辐射计将被设计、制造并集成到 VectRx 中。 潜在的 VectRx 线圈调整为 1) 实现有源和无源 MT 的兼容设计与操作 在 VectRx 内（打开和关闭）；2) 管理 MT 的任何潜在发热、线圈失谐、电场和磁场模式 经过共同开发和优化，MT 的性能将在 VectRx 运行期间保持完整性。 在肝细胞癌 (HCC) Oncopig 模型中建立的 HCC 准确度目标为 1.5°C。 生存率低的疾病，只有一小部分（15%）新诊断的患者有资格接受治疗 该模型与 NTO 的深层次适应症管道相关。 腹部肿瘤，NTO 此前已完成 VectRx 设备的安装并进行了 与伊利诺伊大学的兽医团队在 3 只 HCC Oncopigs 中进行了初步工作，以优化超声波- 引导手术放置光纤探头，用于关联 MT 测量的温度。 尽管轻度 HT 的好处众所周知，但由于技术原因，它尚未在美国广泛采用。 当前技术在解决深部难以加热的肿瘤方面存在局限性，并且缺乏测温技术。 第一阶段项目，我们将证明这些关键缺陷可以通过集成新颖的技术来克服 基于微波的温度技术与 VectRx，提供了先进的创新演示 大型动物肿瘤模型深层组织中 HT 的温度监测。