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: 8740044
• 负责人: MICHAEL R BAILEY
• 金额: $ 38.26万
• 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/8740044
• 关键词: Accident and Emergency department; Acoustics; Acute Pain; Addendum; Address; Affect; Algorithms; American; Calcium Oxalate; Calculi; 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; Patients; Pelvis; Performance; Population; Radiation; Receiver Operator Characteristics; Recurrence; Renal Tissue; Research; Residual state; Resolution; Risk; Scanning; Sensitivity and Specificity; Shadowing (Histology); 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; innovation; 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.项目摘要/摘要 肾结石的治疗方法是手术或警惕等待，在这两种治疗过程中，患者都会暴露在辐射中。 在多项影像检查中。我们建议非侵入性治疗和非电离成像选项，并寻求 验证这些新选项的临床益处。我们的发明是超声波(美国)技术， 配有标准探头和诊断US接口。我们的成像技术解决了以下三个限制 肾结石的常规超声检查：敏感性和特异性差，结石测量不准确 大小和不同运算符之间的可变性能。我们在美国检测到的石头是基于我们在 美国闪烁伪影的病因，AIM 1将测试接收器操作员特征以及 新检测技术与计算机断层扫描(CT)观察的操作员变异性 输尿管镜检查(URS)。目标1还将测试使用该技术通过以下方式指导碎石的结果 冲击波碎石术，我们的检测灵敏度将通过一项新技术-电磁-提高 声学。我们的大小调整技术基于增强石头阴影的图像并测量 阴影的宽度而不是石头的宽度。与图像中的石头识别一样，大小调整是自动完成的，以 减少对操作员的依赖。在目标2中，大小测量将与石头的实际大小进行比较 这将被URS删除。这项技术将通过时间反转声学得到进一步增强，并进行测试 解决CT不太可能准确测量的亚临床结石。此外，我们的技术增加了 利用探头发出的美国波重新定位肾脏结石的能力。这样做的临床益处 超声推进(UP)将在AIM 3中进行测试。从弹丸中排出的残留碎片的清除率 UP的肾脏将与未经治疗的人类受试者进行测试。同样在Aim 3中，UP将进行缓解疼痛的测试 和肾积水通过移位来自输尿管-盆腔交界处的紧急梗阻结石逆行至 肾脏。在目标4中，我们将通过消除无症状来测试在人类受试者中减少复发的情况 亚临床结石来自肾结石伴URS或以上。因此，这项建议具有创新性， 有可能给治疗带来革命性的变化。结石病很严重，影响了10%的人口，我们的 这些发明可以减少患者的辐射暴露，减轻患者的痛苦，减少急诊室的使用， 避免手术，在不排除现有选择的情况下，削减相当一部分结石患者的成本。这 提案很可能会成功，因为它侧重于对已演示的 原型。最后，该提案是密切协作、相互依存的计划项目协调的一部分 由Core A开发，并符合更广泛的治疗革命。核心B已经制定并将管理适当的 研究的统计框架。在Project 2中，我们的成像将用于引导一种新的非侵入性结石 粉碎技术称为冲击波碎石，在项目3中，UP将用于改善电流 通过预防性地清除亚临床结石来预防手术。