Ultrasound Ablation on Bone Cancer Under CT Fluoroscopy

描述（由申请人提供）：在美国，转移性骨癌和多发性骨髓瘤每年影响超过60万人，并导致进行性骨破坏，导致严重疼痛、骨折和无法行走。患者通常表现为继发于骨骼受累、伴或不伴椎体塌陷、脊髓和/或神经根受压的丧失行为能力的疼痛，通常导致截瘫和四肢瘫痪。常规治疗包括卧床休息、支具、抗炎或麻醉镇痛药物和放射治疗。这些保守的选择（除了放射治疗）与骨质疏松性压缩性骨折的治疗没有什么不同，并且与相同类型的并发症相关，即肺不张和肺炎，深静脉血栓形成和肺栓塞。并非所有患者都可以选择外科手术，但当有必要时，它们包括严重的干预措施，如椎体切除术或笼子放置，手术后恢复期长，并且通常预期寿命有限的患者的发病率和死亡率高。此外，多灶性椎体病变是常见的，可能忌讳手术。椎体成形术影响疼痛症状，并不是为治疗癌症而设计的。目前转移性脊柱癌局部治疗的选择是不够的。假设与肿瘤大小和形状相匹配的高强度间质超声（HIIU）热消融在转移性脊柱癌的治疗中是安全有效的。我们建议建立一种在计算机断层扫描（CT）和CT透视（CTF）联合引导下进行微创适形超声消融的机制。我们的工作表明，这种方法可能以一种简单、经济有效的方式提供一致、可靠和安全的治疗选择。我们的方法的独特之处在于能够用一根针破坏不对称的目标体积，而不需要将其放置在病变的中心。在CT/CTF图像引导下，我们插入烧蚀器，相对于目标区域定位烧蚀器，然后电子塑造能量输出以符合目标。因此，适度的放置误差可以简单地通过电子方式纠正。我们也可以烧蚀位于敏感结构附近的复杂形状。临床迫切需要提供一种方法，在这个敏感区域以集中和安全的方式杀死肿瘤，保护脊髓，肿瘤可能已经在脊髓周围造成严重的骨破坏。使能量与肿瘤形状一致的能力具有清晰的边缘场是至关重要的，并将增加非常重要的临床价值。本项目将开发一种集成的仪器-消融治疗递送系统，在实时定量CT/CTF指导下建立安全准确的经皮HIIU置针和肿瘤消融，制定适当的临床工作流程，并在临床应用中进行演示。

DESCRIPTION (provided by applicant): Metastatic bone cancer and multiple myeloma affects over 600,000 people every year in the United States and cause progressive bone destruction that results in severe pain, fractures, and the inability to walk. Patients usually present with incapacitating pain secondary to osseous involvement, with or without vertebral collapse, and to spinal cord and/or nerve roots compression, commonly leading to paraplegia and quadriplegia. Conventional therapy consists of bed rest, bracing, anti-inflammatory, or narcotic analgesic medications, and radiation therapy. These conservative options (except radiation therapy) are not dissimilar from the management of osteoporotic compression fractures and are associated with the same type of complications, i.e., atelectasis and pneumonia, deep venous thrombosis and pulmonary embolism. Surgical options are not possible for all patients, but when indicated, they consist of heavy interventions such as corpectomy or cage placement, with significant postprocedural recovery periods and high morbidity and mortality rates in patients who often have limited life expectancies. In addition, multifocal vertebral lesions are common and may contraindicate surgery. Vertebroplasty affects the pain symptom and was not designed to treat cancer. Current options for local treatment of metastatic spine cancer are insufficient. The hypothesis is that thermal ablation with high intensity interstitial ultrasound (HIIU) specifically matched to the tumor size and shape can be safe and efficacious in the management of metastatic spine cancer. We propose to develop a mechanism to perform minimally invasive conformal ultrasound ablation under combined computer tomography (CT) and CT fluoroscopy (CTF) guidance. Our work indicates that this method may provide a consistent, reliable, and safe treatment option in a simple and cost-efficient manner. The unique aspect of our approach is the ability to destruct an asymmetric target volume with a single needle that does not need to be placed in the center of the lesion. Under CT/CTF image guidance, we insert the ablator, localize the ablator with respect to the target zone, and then electronically shape the energy output to conform the target. Thus moderate placement errors can be simply corrected electronically. We also can ablate difficult shapes located nearby sensitive structures. There is a strong clinical need to deliver a means to kill the tumor in a focused and safe way in this sensitive area, protecting the spinal cord, around which the tumor is likely to have caused significant bone destruction already. The ability to conform the energy to the shape of the tumor with a sharply defined fringe field is critical and would add very significant clinical value. This program will develop an integrated instrumentation - ablative treatment delivery system, establish safe and accurate percutaneous HIIU needle placement and tumor ablation under real-time quantitative CT/CTF guidance, develop appropriate clinical workflow, and demonstrate use in clinical application.