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.

这种小型企业技术转移（STTR）II期项目的更广泛的影响/商业潜力是一种新型的生物相容性凝胶，可提高热肿瘤消融程序的有效性和安全性。该技术增强了射频能量的能量介质，从而导致更有效的肿瘤电穿孔，从而增加了能量的治疗浓度，同时最大程度地减少了对周围烟道或组织的意外损害。 The technical 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改善局灶性肿瘤消融过程中的程序结果。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目标区域，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，将使用肝，肾脏和肌肉组织在体内临床前模型和磁共振成像中收集临床前数据，以量化温度，消融区的大小和热能沉积。在第三阶段，将使用体内猪肺和标准的非侵入性临床成像方法评估组织消融过程中的凝胶作用。在第四阶段，将完成一项体内慢性安全研究。完成后，这些里程碑的结果将提供必要的临床前证据，以首先在人类研究中启动。该奖项反映了NSF的法定任务，并被认为是通过基金会的知识分子优点和更广泛的影响来评估的评估，被视为珍贵的支持。