STTR Phase II: Thermal Imaging, Augmentation of Microwave Energy in Various Tissues and Chronic Safety

STTR 第二阶段：热成像、增强各种组织中的微波能量和长期安全性

• 批准号: 2301440
• 负责人: William Park
• 金额: $ 100万
• 依托单位: THEROMICS INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-03-15 至 2026-02-28
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2301440&HistoricalAwards=false
• 关键词: STTR; Phase; II; Thermal; Imaging

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is a novel biocompatible gel to improve the effectiveness and safety of thermal tumor ablation procedures. The technology enhances the energy medium of radiofrequency energy, resulting in more effective electroporation of tumors, increasing the therapeutic concentration of energy while minimizing unintended damage to surrounding fluids or tissues. The technological medium aims to improve procedural outcomes for the $800 million and $2.7 billion worldwide image-guided thermal ablation market, with broad applicability for a wide variety of ablation procedures, including those performed for endometrial bleeding, pain management, spinal decompression and denervation, benign prostatic hyperplasia, and emphysema reduction.This Small Business Technology Transfer Phase II project aims to develop a novel protein-based gel for improving procedural outcomes during focal tumor ablation procedures. This novel material provides a viscous fluid medium for focusing radiofrequency energy intensity to its intended target area in order to intensify localized energy delivery. During the first phase, a computational model will be developed using 3D microwave imaging under simulated clinical conditions to predict the thermal behavior of the gel. During the second phase, preclinical data will be collected using liver, kidney, and muscle tissue in vivo preclinical models and magnetic resonance imaging to quantify temperatures, ablation zone size, and thermal energy deposition. During the third stage, the gel’s effects during tissue ablation will be assessed using in vivo porcine lung and standard non-invasive clinical imaging methods. During the fourth phase, an in vivo chronic safety study will be completed. Upon completion, the results from these milestones will provide the necessary preclinical evidence to initiate first in human studies.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这项小型企业技术转移（STTR）二期项目的更广泛影响/商业潜力是一种新型生物相容性凝胶，可提高肿瘤热消融手术的有效性和安全性。该技术增强了射频能量的能量介质，导致更有效的肿瘤电穿孔，增加治疗能量浓度，同时最大限度地减少对周围液体或组织的意外损伤。该技术媒介旨在改善价值8亿美元和27亿美元的全球图像引导热消融市场的手术效果，广泛适用于各种消融手术，包括子宫内膜出血、疼痛管理、脊柱减压和去神经支配、良性前列腺增生和肺气肿减少。这个小型企业技术转移二期项目旨在开发一种新的基于蛋白质的凝胶，以改善局灶性肿瘤消融过程中的手术结果。这种新型材料提供了一种粘性流体介质，用于将射频能量强度聚焦到预定的目标区域，以加强局部能量输送。在第一阶段，将使用模拟临床条件下的三维微波成像来开发计算模型，以预测凝胶的热行为。在第二阶段，将使用肝脏、肾脏和肌肉组织的体内临床前模型和磁共振成像来收集临床前数据，以量化温度、消融区大小和热能沉积。在第三阶段，将使用活体猪肺和标准的非侵入性临床成像方法评估凝胶在组织消融期间的效果。在第四阶段，将完成一项体内慢性安全性研究。完成后，这些里程碑的结果将提供必要的临床前证据，以启动首次人体研究。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。