Ultrasound Ablation on Bone Cancer Under CT Fluoroscopy

CT透视下骨癌超声消融

• 批准号: 7805551
• 负责人: Everette C Burdette
• 金额: $ 108.38万
• 依托单位: ACOUSTIC MEDSYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-21 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7805551
• 关键词: Ablation; Acoustics; Adult; Affect; Aftercare; Algorithms; Anatomy; Anesthesia procedures; Animal Model; Animals; Anti-Inflammatory Agents; Anti-inflammatory; Area; Atelectasis; Back Pain; Bed rest; Biomedical Research; Bone Diseases; Bone neoplasms; Braces-Orthopedic appliances; Caliber; California; Cancer Model; Cancer Patient; Cannulas; Cardiopulmonary; Cervical; Clinical; Clinical Research; Collaborations; Common Neoplasm; Compression Fracture; Computer software; Computers; Conduction Anesthesia; Data; Deep Vein Thrombosis; Deposition; Development; Devices; Diagnosis; Diagnostic; Disease; Dose; Electronics; Elements; Equipment; Evaluation; Family; Family suidae; Feedback; Financial compensation; Fluoroscopy; Fracture; Funding; Grant; Hematologic Neoplasms; Hospitals; Human; Image; Intervention; Joints; Learning; Length; Lesion; Life Expectancy; Local Therapy; Location; Lymphoma; Lytic Metastatic Lesion; Magnetic Resonance Imaging; Malignant - descriptor; Malignant Bone Neoplasm; Malignant Neoplasms; Malignant neoplasm of prostate; Marketing; Mechanics; Medical Technology; Metastatic Lesion; Metastatic Neoplasm to the Bone; Methodology; Methods; Modeling; Monitor; Morbidity - disease rate; Multiple Myeloma; Narcotic Analgesics; Needles; Neoplasm Metastasis; Nerve Root Compressions; Neurologic Dysfunctions; Operative Surgical Procedures; Osteolysis; Outcome; Outpatients; Output; Pain; Palliative Care; Paraparesis; Paraplegia; Pathological fracture; Patients; Pattern; Penetration; Performance; Pharmaceutical Preparations; Phase; Physicians; Pilot Projects; Pneumonia; Positioning Attribute; Preparation; Preventive; Procedures; Pulmonary Embolism; Quadripareses; Quadriplegia; Radial; Radiation therapy; Radiofrequency Interstitial Ablation; Radiology Specialty; Radiopharmaceuticals; Recovery; Research; Research Subjects; San Francisco; Scheme; Secondary to; Shapes; Skeletal system; Specific qualifier value; Spinal; Spinal Cord; Spinal Neoplasms; Structure; Surface; Symptoms; System; Systems Integration; Techniques; Technology; Temperature; Tern; Testing; Therapeutic; Thermal Ablation Therapy; Time; Tissues; Toxic effect; Transducers; Ultrasonography; United States; Universities; Variant; Vertebral column; Walking; Work; base; bisphosphonate; body system; bone; cancer therapy; chemotherapy; clinical application; clinical practice; computerized data processing; conventional therapy; cost; design; dosimetry; flexibility; high risk; hormone therapy; improved; in vivo; instrumentation; interstitial; intraoperative imaging; killings; minimally invasive; mortality; neoplastic; pre-clinical; prevent; programs; prototype; public health relevance; research study; sensor; skills; spinal cord compression; spine bone structure; standard care; success; technology development; tomography; treatment planning; tumor; validation studies; vertebra body

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. PUBLIC HEALTH RELEVANCE: Vertebral metastatic disease is the most common malignant disease of the skeletal system and the most common causes of bone destruction in adult patients. Over 600,000 patients per year have progressive bone disease requiring treatment. Progressive bone destruction results in debilitating pain, fractures, and the inability to walk. Traditional techniques have been based on open surgery with potentially substantial surgery-associated morbidity. In addition, many patients may not possess sufficient cardiopulmonary reserve to undergo major spinal procedures. As a result, many of the affected patients are receiving palliative care with only symptomatic treatment of pain and paraparesis or quadriparesis. The first objective in treatment is to alleviate pain and prevent complications such as pathologic fractures, which is especially important in patients with spinal metastasis to avoid instability and neurologic dysfunction. The standard treatments include radiation therapy, surgery, chemotherapy, hormone therapy, and, recently, therapy using systemic radiopharmaceuticals and biphosphonates; radiotherapy remains the treatment of choice. However, the long-term results of these treatments are not satisfying; an effective, minimally invasive local therapy that can be performed at a single outpatient setting would be beneficial. Minimally invasive procedures have been developed to replace standard procedures but most patients still require general and regional anesthesia and the procedures are only moderately minimally invasive. Percutaneous image-guided needle- based surgery is the least invasive mode of intervention practiced today and numerous variations of these techniques have been demonstrated to have high efficacy with low morbidity and low cost across many diseases and organ systems. It is, therefore, a logical imperative to explore percutaneous therapy in the management of metastatic spine cancer. For patients with tumoral spine disease, currently there is no adequate alternative to the immediate pain relief and minimal-invasiveness of percutaneous vertebroplasty. At the same time, however, the mechanism for pain relief in neoplastic lesion is not completely understood, thus vertebroplasty is still debated, and its efficacy has been proven so far on a very limited basis. Besides, the aim of vertebroplasty is pain relief and not eradication of the cancer. Percutaneous vertebroplasty is currently best indicated in patients complaining of a severe, focal, and mechanical back pain related to a neoplastic vertebral collapse without epidural involvement. In our practice, without spinal cord compression or epidural involvement, partial osteolysis of the posterior wall of the vertebral body is not a contraindication [Murphy-2000, Vasconcelos-2002]. Preventive treatment of osteolytic lesions at high risk of vertebral collapse in asymptomatic patients seems to be highly appropriate. Percutaneous vertebroplasty is rarely indicated at the cervical and cervicothoracic junction but may be of value in cases where surgery is contraindicated. These are the patients who would benefit the most from percutaneous US ablation of their bone cancer. Our approach 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. Toward proving this hypothesis, we propose to develop a mechanism to perform minimally invasive conformal ultrasound ablation under combined computer tomography (CT) and CT fluoroscopy (CTF) guidance. In summary, the most unique aspect of HIIU ablation 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 intraoperative image guidance, one could insert the ablator to a safe location with respect to the surrounding anatomy, localize the ablator with respect to the target zone, and then electronically shape the energy output to conform the target. This approach will allow for electronic compensation of moderate needle placement errors and for the ablation of difficult shapes located nearby sensitive structures.

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，并造成渐进的骨骼破坏，导致严重的疼痛，骨折和无法行走。患者通常出现骨间参与，有或没有椎骨塌陷的丧失能力的疼痛，以及脊髓和/或神经根部压缩，通常导致瘫痪和四肢瘫痪。常规治疗包括床休息，支撑，抗炎或麻醉镇痛药和放射治疗。这些保守的选择（放射疗法除外）与骨质疏松压缩裂缝的治疗并不相同，并且与相同类型的并发症，即肺炎症和肺炎，深静脉血栓形成和肺栓塞有关。所有患者都无法进行手术选择，但是当指示时，它们包括诸如切割或笼子置换的大干预措施，术后恢复期明显，并且在预期寿命有限的患者中的发病率和高发病率和死亡率很高。此外，多灶性椎体病变很常见，可能会进行禁忌手术。椎体成形术会影响疼痛症状，并非旨在治疗癌症。当前局部治疗转移性脊柱癌的选择不足。假设是，与肿瘤大小和形状相匹配的高强度间隙超声（HIIU）的热消融在转移性脊柱癌的管理中可以安全有效。我们建议制定一种在组合计算机断层扫描（CT）和CT荧光镜检查（CTF）指导下进行微创保形超声消融的机制。我们的工作表明，此方法可以简单且具有成本效益的方式提供一致，可靠和安全的治疗选择。我们方法的独特方面是能够用单针破坏不对称的目标体积，而无需将其放置在病变的中心。在CT/CTF图像指导下，我们插入射击器，将射击器定位在目标区域，然后以电子方式塑造能量输出以构成目标。因此，可以简单地通过电子纠正中等位置误差。我们还可以消除附近敏感结构的困难形状。在该敏感区域中，以重点且安全的方式杀死肿瘤的方法有很大的临床需求，以保护脊髓，脊髓可能已经造成了巨大的骨骼破坏。将能量与肿瘤形状构成与明确定义的条纹场的能力至关重要，并且会增加非常重要的临床价值。该计划将开发综合仪器 - 消融治疗输送系统，在实时定量CT/CTF指导下建立安全，准确的经皮HIIU针头和肿瘤消融，开发适当的临床工作流程，并证明在临床应用中使用。 公共卫生相关性：椎骨转移性疾病是骨骼系统中最常见的恶性疾病，也是成年患者骨骼破坏的最常见原因。每年超过600,000名患者患有骨骼疾病需要治疗。进行性骨骼破坏导致疼痛，断裂和无法行走。传统技术是基于开放手术，具有潜在的与手术相关的发病率。此外，许多患者可能没有足够的心肺储备来进行主要的脊柱手术。结果，许多受影响的患者正在接受姑息治疗，仅对疼痛和模拟或四次促治疗。治疗的第一个目标是减轻疼痛和预防并发症，例如病理性骨折，这在脊柱转移患者中尤其重要，以避免不稳定和神经功能障碍。标准疗法包括放射疗法，手术，化学疗法，激素治疗以及最近使用全身放射性药物和双膦酸盐治疗。放疗仍然是选择的治疗方法。但是，这些治疗的长期结果并不令人满意。可以在单一门诊环境下进行的有效，微创的局部疗法将是有益的。已经开发了最小的侵入性程序来替代标准程序，但大多数患者仍然需要一般和区域麻醉，并且该程序仅是中等最小的侵入性。经皮图像引导的基于针头的手术是当今实践的最小入侵性干预模式，并且已经证明，许多疾病和器官系统中，这些技术的多种变化具有高疗效，发病率低，成本低。因此，在转移性脊柱癌的管理中探索经皮治疗是逻辑上的逻辑。对于患有肿瘤脊柱疾病的患者，目前尚无足够的替代性替代椎间盘成形术的疼痛缓解和最小的侵入性。然而，与此同时，尚不完全了解肿瘤病变疼痛的机制，因此椎体成形术仍在争论中，并且其功效已在非常有限的基础上得到证明。此外，椎体成形术的目的是缓解疼痛，而不是根除癌症。经皮脊椎样品成形术目前最好在抱怨与肿瘤椎骨塌陷有关而没有硬膜外受累的严重，局灶性和机械背痛的患者中表明。在我们的实践中，没有脊髓压缩或硬膜外介入，椎体后壁的部分骨溶解不是禁忌症[Murphy-2000，Vasconcelos-2002]。无症状患者对椎骨塌陷高风险的骨化病变的预防治疗似乎非常合适。经皮椎骨成形术很少在宫颈和宫颈胸部连接处指示，但在禁忌手术的情况下，可能具有价值。这些患者将从经皮的美国消融骨癌中受益最大。我们的接近热消融具有与肿瘤大小和形状相匹配的高强度间隙超声（HIIU）的高强度，在转移性脊柱癌的管理中可以安全有效。为了证明这一假设，我们建议开发一种在组合计算机断层扫描（CT）和CT荧光镜（CTF）指南下进行最小侵入性保形超声消融的机制。总而言之，HIIU消融的最独特方面是能够用单针破坏不对称的目标体积，而无需将其放置在病变的中心。在术中图像指导下，可以将射击器插入到周围解剖结构的安全位置，从而将消化器相对于目标区域进行定位，然后以电子方式塑造能量输出以构成目标。这种方法将允许电子补偿中等针头误差，并消除附近敏感结构的困难形状。