Ultrasound Ablation of Bone Cancer Under CT Fluoroscopy

描述（由申请人提供）：骨癌和多发性骨髓瘤在美国每年影响超过60万人，并导致进行性骨破坏，导致疼痛、骨折和无法行走。该提案的假设是，高强度间质超声（HIIU）热消融可有效治疗转移性骨癌。我们建议开发一种在计算机断层扫描（CT）和CT荧光透视（CTF）联合引导下进行微创适形骨消融的机制。我们将证明这种方法以简单和具有成本效益的方式提供了一致，可靠和安全的治疗选择。我们建议经典的医疗技术开发分两步完成：首先开发适当的核心技术，然后在1期临床试验中进行评估。该项目的可交付成果包括：（1）集成医疗器械的先进原型，可供监管部门批准和随后的商业引入;（2）使用该器械治疗转移性脊柱癌的临床方法。特别地，我们将应用声学消融针，将其经皮插入目标附近的骨中。 1期研究将确定在实时定量CT/CTF引导下安全准确的经皮HIIU穿刺针放置和消融的可行性。具体目标如下： 目标一：图像引导：为消融器械的立体定向图像引导和消融术的术中优化开发方法、硬件和软件组件。 目标二：HIIU施用器：按照Aim-1中开发的引导方法，将声学消融导管包装在经皮导入骨组织的针中。 目的-3：动物研究：使用目的1和2中开发的系统在离体和体内动物模型中进行可行性研究。

DESCRIPTION (provided by applicant): Bone cancer and multiple myeloma affects over 600,000 people every year in the United States and causes progressive bone destruction that results in pain, fractures, and the inability to walk. The hypothesis of the proposal is that thermal ablation with high intensity interstitial ultrasound (HIIU) is efficacious in management of metastatic bone cancer. We propose to develop a mechanism to perform minimally invasive conformal bone ablation under combined computer tomography (CT) and CT fluoroscopy (CTF) guidance. We will prove that this method provides a consistent, reliable, and safe treatment option in a simple and cost-efficient manner. We propose classic medical technology development accomplished in two steps: first the development of appropriate core technology, and then the evaluation of that in a Phase-1 clinical trial. The deliverables of the program will be (1) an advanced prototype of an integrated medical device that is ready for regulatory approval and subsequent commercial introduction, (2) clinical methodology for the use of this device to treat metastatic spine cancer. In particular, we will apply acoustic ablative needles to be inserted percutaneously into the bone near the target. Phase-1 research will establish the feasibility of safe and accurate percutaneous HIIU needle placement and ablation under real-time quantitative CT/CTF guidance. Specific aims are as follows: Aim-1: Image Guidance: Develop methodology, hardware, and software components for sterotactic image guidance of the ablator device and intra-operative optimization of the ablation. Aim-2: HIIU Applicator: Package an acoustic ablator catheter in a needle for percutaneous introduction to bony tissues, compliant to the guidance method developed in Aim-1. Aim-3: Animal Studies: Perform feasibility studies in ex-vivo and in-vivo animal models with the system developed in Aims 1 and 2.