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.

项目摘要/摘要 Neotherma肿瘤学（NTO/www.neothermaoncology.com）开发了一种新颖的非侵入性医疗设备 这可以在调整疗法的情况下为适应的治疗治疗 腹部深处肿瘤。 FDA设计的“突破”的VectRX™设备具有 在临床前研究中证明了其安全腹部器官（胰腺，肝脏，肾脏，囊）的能力 在健康的猪中。 FDA根据这些数据批准了VECTRX的投资设备豁免， 缺乏用于胰腺癌的大型动物肿瘤模型。 NTO早期发起了第一个 马里兰大学医学中心的可行性研究（EFS）研究，以收集最初的安全性和绩效 胰腺癌患者的数据。 与EFS并行，NTO将与科罗拉多大学 - 博尔德大学的研究人员合作 微波温度计（MT）可用于无创测量深组织中的温度。 这种发展基于检测与温度成正比的黑体辐射的能力 从皮肤到深层组织的不同组织深度发射。成功整合MT将有效地 改善VECTRX的临床实用性。这将解决有限的可用性，访问，高的挑战姿势 成本，逻辑问题和专业人员的缓解，磁共振也是如此 温度法。将设计，制造和集成到Vectrx中 潜在的VECTRX线圈调整到1）实现运行的主动和被动MT的兼容设计 在vectrx中（开和关）； 2）管理MTS的任何潜在加热，线圈失调，电子场和H场图案 VECTRX操作期间的完整性。遵循共同开发和优化，MTS的性能将是 在肝细胞癌（HCC）Oncopig模型中建立，其精度为1.5°C。 HCC是一个 生存率低，只有一小部分（15％）的疾病有资格 由于晚期诊断而导致的治疗方法。该模型与NTO的指示管道有关 腹部肿瘤，NTO先前已经完成了VectRX设备的安装并进行了 伊利诺伊大学兽医团队在3 HCC Oncopigs中进行初步工作，以优化超声波 指导的手术放置光纤问题，这些问题将用于与MTS测量的温度相关。 尽管有轻度HT的已知好处，但由于技术的技术，它在美国尚未被广泛采用 当前技术的局限性解决深度，难以加热肿瘤和缺乏温度法。在这个 第一阶段项目，我们将证明这些关键缺陷可以通过整合新颖 基于微波的温度技术，具有VECTRX，提供了先进的创新演示 大型动物肿瘤模型中深层组织中HT的温度监测。