Novel Ultrasound Modalities to Detect, Characterize and Remove Stones

用于检测、表征和去除结石的新型超声波模式

• 批准号: 9088404
• 负责人: MICHAEL R BAILEY
• 金额: $ 35.79万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9088404
• 关键词: Accident and Emergency department; Acoustics; Acute Pain; Addendum; Address; Affect; Algorithms; American; Calcium Oxalate; Clinical; Clinical Trials; Collaborations; Computers; Daughter; Dependence; Detection; Devices; Disease; Dose-Limiting; Ductal; Economic Burden; Electroconvulsive Therapy; Electromagnetic Energy; Electromagnetics; Emergency Situation; Etiology; Event; Excision; FDA approved; Feasibility Studies; Financial compensation; Future; Human; Hydronephrosis; Image; Imaging technology; Indiana; International; Ipsilateral; Kidney; Kidney Calculi; Lithotripsy; Measurement; Measures; Metabolic Clearance Rate; Methods; Minerals; Modality; Monitor; Morphologic artifacts; Motion; Nephrolithiasis; Obstruction; Operative Surgical Procedures; Outcome; Pain; Parents; Patient observation; Patient-Focused Outcomes; Patients; Pelvis; Performance; Population; Radiation; Receiver Operating Characteristics; Recurrence; Renal Tissue; Research; Residual state; Resolution; Risk; Scanning; Sensitivity and Specificity; Shock; Site; Technology; Testing; Time; Treatment Cost; Ultrasonic wave; Ultrasonics; Ultrasonography; Universities; Ureter; Ureteroscopy; Urologic Diseases; Urologist; Validation; Washington; Width; X-Ray Computed Tomography; abstracting; base; clinically significant; cost; effective therapy; follow-up; human subject; improved; improved outcome; innovation; invention; new technology; novel; prevent; programs; prospective; prototype; tomography; urologic

7. Project Summary/Abstract Nephrolithiasis is treated by surgery or watchful waiting, and in either course, patients are exposed to radiation in multiple imaging exams. We propose noninvasive treatment and non-ionizing imaging options and seek to validate the clinical benefit of these new options. Our invention is ultrasound (US) technology that operates with a standard probe and diagnostic US interface. Our imaging technology addresses three limitations of conventional US imaging for nephrolithiasis: poor sensitivity and specificity, inaccurate measurement of stone size, and variable performance among operators. Our US detection of stones is based on our new findings on the etiology of the US twinkling artifact, and Aim 1 will test the receiver operator characteristics as well as inter- operator variability of the new detection technology versus observation in computer tomography (CT) and ureteroscopy (URS). Aim 1 will also test outcomes of using the technology to guide comminution of stones by shock wave lithotripsy, and our detection sensitivity will be augmented by a new technology, electromagnetic acoustics. Our sizing technology is based on enhancing the image of the stone's shadow and measuring the width of the shadow not the stone. Sizing, as with stone identification within the image, is done automatically to reduce the operator dependence. In Aim 2, size measurement will be compared to the actual size of stones that will be removed by URS. The technology will be further enhanced by time reversal acoustics and tested to resolve subclinical stones not likely to be measured accurately by CT. Additionally, our technology adds the capability to use the US waves from the probe to reposition stones in the kidney. The clinical benefit of this ultrasonic propulsion (UP) will be tested in Aim 3. The clearance rate of residual fragments expelled from the kidney by UP will be tested versus untreated human subjects. Also in Aim 3, UP will be tested for relieving pain and hydronephrosis by displacing emergent obstructing stones from the uretero-pelvic junction retrograde to the kidney. In Aim 4, we will test for reduction in recurrence among human subjects by removing asymptomatic subclinical stones from the kidney with URS or UP. As such, this proposal possesses innovation with the potential to revolutionize treatment. Stone disease is significant, affecting 10% of the population, and our inventions stand to reduce patient radiation exposure, reduce patient pain, reduce emergency room usage, avoid surgeries, and cut costs for a significant subset of stone patients without precluding existing options. This proposal is likely to succeed because it focuses on specific, testable, clinical validation of a demonstrated prototype. Lastly, the proposal is part of a closely collaborative, interdependent Program Project coordinated by Core A, and fits within a broader treatment revolution. Core B has devised and will administer the proper statistical framework for the studies. With Project 2, our imaging will be used to guide a new noninvasive stone comminution technology called burst wave lithotripsy, and with Project 3, UP will be used to improve current SWL and prevent surgeries by prophylactically removing subclinical stones.

7.项目总结/摘要 肾结石的治疗方法是手术或观察等待，在这两个过程中，患者暴露于辐射 在多个成像检查中。我们提出了非侵入性治疗和非电离成像的选择，并寻求 验证这些新选择的临床益处。我们的发明是超声波技术， 带有标准探头和诊断US接口。我们的成像技术解决了以下三个局限性： 肾结石的常规超声成像：敏感性和特异性差，结石测量不准确 规模和运营商之间的可变性能。我们在美国发现的结石是基于我们对 US闪烁伪影的病因，Aim 1将测试接收器操作员特性以及内部 新检测技术与计算机断层扫描（CT）观察的操作员可变性， 输尿管镜检查（URS）。目标1还将测试使用该技术指导碎石的结果， 冲击波碎石术，我们的检测灵敏度将通过一种新技术，电磁 声学.我们的尺寸测量技术是基于增强石头的阴影图像和测量 影子的宽度不是石头的宽度。尺寸调整，与图像中的宝石识别一样，是自动完成的， 减少对运营商的依赖。在目标2中，尺寸测量将与结石的实际尺寸进行比较 会被URS移除该技术将通过时间反转声学进一步增强，并进行测试， 解决CT无法准确测量的亚临床结石。此外，我们的技术还增加了 能够使用来自探头的US波来重新定位肾脏中的结石。这种方法的临床益处 超声推进（UP）将在Aim 3中进行测试。术后排出的残余碎片的清除率 将相对于未治疗的人类受试者测试UP的肾脏。同样在目标3中，UP将被测试用于缓解疼痛 和肾积水，通过将紧急梗阻结石从输尿管肾盂连接处逆行移位到 肾脏在目标4中，我们将通过去除无症状的患者， 来自URS或UP的肾的亚临床结石。因此，该建议具有创新性， 有可能彻底改变治疗方法。结石病是显著的，影响10%的人口，我们的 本发明致力于减少患者辐射暴露，减少患者疼痛，减少急诊室使用， 避免手术，并在不排除现有选择的情况下，为相当一部分结石患者削减成本。这 一项提案很可能会成功，因为它侧重于对已证明的 样机最后，该提案是一个密切合作，相互依存的计划项目的一部分， 由核心A，并适合在一个更广泛的治疗革命。核心B已经设计并将管理适当的 研究的统计框架。在项目2中，我们的成像将用于引导新的非侵入性结石 粉碎技术称为爆破波碎石术，并与项目3，UP将用于改善电流 SWL和预防外科手术，通过主动清除亚临床结石。