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

这个小企业技术转移(STTR)第二阶段项目的更广泛的影响/商业潜力是一种新型的生物兼容凝胶，可以提高热肿瘤消融术的有效性和安全性。该技术增强了射频能量的能量媒介，导致对肿瘤的更有效的电穿孔，增加了治疗能量的集中，同时将对周围液体或组织的意外损害降至最低。该技术介质旨在改善价值8亿美元和27亿美元的全球图像引导热消融市场的程序结果，广泛适用于各种消融程序，包括子宫内膜出血、疼痛管理、脊柱减压和去神经、良性前列腺增生和肺气肿减少。这个小企业技术转移第二阶段项目旨在开发一种新型的基于蛋白质的凝胶，用于改善局部肿瘤消融程序的程序结果。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其预期的靶区，以加强局部能量传递。在第一阶段，将在模拟临床条件下使用3D微波成像开发计算模型，以预测凝胶的热行为。在第二阶段，将使用体内的肝、肾和肌肉组织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该凝胶在组织消融过程中的效果。在第四阶段，将完成体内慢性安全性研究。完成后，这些里程碑的结果将为启动人类研究提供必要的临床前证据。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.