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.

该小型企业技术转移（STTR）第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，可提高热肿瘤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，从而实现更有效的电穿孔。该技术媒介旨在改善全球 8 亿美元和 27 亿美元的图像引导热消融市场的手术结果，并具有广阔的前景。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手术。这个小型企业技术转让第二期项目旨在开发一种新型蛋白质凝胶，用于治疗这种新型材料提供了一种粘性流体介质，可将射频能量强度聚焦到其预期目标区域，以增强局部能量输送。将在模拟临床条件下使用 3D 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、肾脏和肌肉组织体内临床前模型和磁共振成像来收集临床前数据以进行量化。在第三阶段，将使用体内猪肺和标准非侵入性临床成像方法评估凝胶在组织消融过程中的影响。在第四阶段，将进行体内慢性安全性研究。将要完成后，这些里程碑的结果将为首先开展人体研究提供必要的临床前证据。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。