Ultrasound Ablation of Bone Cancer Under CT Fluoroscopy

描述(申请人提供)：骨癌和多发性骨髓瘤在美国每年影响60多万人，并导致进行性骨骼破坏，导致疼痛、骨折和无法行走。该方案的假设是高强度间质超声(HIIU)热消融治疗转移性骨癌是有效的。我们建议开发一种在计算机断层扫描(CT)和CT透视(CTF)联合指导下进行微创适形骨消融的机制。我们将证明，这种方法以一种简单、经济的方式提供了一种一致、可靠和安全的治疗方案。我们提出经典医学技术的开发分两个步骤完成：首先开发合适的核心技术，然后在一期临床试验中对其进行评估。该计划的成果将是(1)一种集成医疗设备的先进原型，该设备已准备好等待监管部门的批准和随后的商业推出，(2)使用该设备治疗转移性脊柱癌症的临床方法。特别是，我们将应用声学消融针，将其经皮插入靶区附近的骨骼。第一阶段研究将确定在实时定量CT/CTF引导下安全、准确地经皮放置和消融HIIU针的可行性。具体目标如下： 目标-1：图像引导：为消融器设备的立体定向图像引导和术中消融的最优化开发方法学、硬件和软件组件。Aim-2：HIIU敷贴器：按照AIM-1中开发的引导方法，将声学消融器导管包装在针内，用于经皮骨组织导入。 目标-3：动物研究：利用目标1和目标2中开发的系统，在体外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.