A Double-Blinded Comparison of the Accuracy of ShuntCheck, a Non-Invasive Device

描述(由申请人提供)：这一阶段的SBIR将开发一种非侵入性的替代放射性核素分流通畅测试，用于评估正常压力脑积水(NPH)患者疑似分流故障。脑积水是一种脑脊液动力学障碍，通常通过放置分流管将多余的液体从大脑输送到腹部进行治疗。虽然这种治疗总体上是成功的，但分流手术不可避免地失败了，通常是由于梗阻。分流梗阻的临床症状，逐渐下降为痴呆症样症状，使分流失败的诊断具有挑战性。NPH患者的可疑梗阻通常采用有创的放射性核素分流通畅研究进行调查。目前尚无非侵入性、非放射学技术用于分流梗阻的早期诊断。NeuroDx Development(NeuroDx)正在开发一种名为ShuntCheck的工具，用于在冷却的脑脊液通过分流管移动时，通过经皮温度检测来快速、非侵入性地测量通过VP分流管的脑脊液流量。由此产生的手持式装置是一种快速确定分流功能的方便方法。将该设备转化为NPH诊所的关键是完成一项临床验证研究，以比较该设备与放射性核素测试的诊断敏感性和特异性。这个第一阶段项目的目标是完成一项25名患者的ShuntCheck与放射性核素的临床对比研究。在第二阶段，我们预计将进行一项多中心的分流检查结果研究，作为NPH患者的分流通畅性测试。这项研究将作为一项关键试验进行，并将用于支持ShuntCheck的扩展标签。这项研究的结果可能是对目前用于管理有症状的NPH患者的诊断算法的重要改变。考虑到对准确诊断分流故障的非侵入性方法的需求、与替代方法相比的潜在节省以及改善患者预后的可能性，这项研究的数据将支持一种商业上可行且极其重要的产品。 公共卫生相关性：通过支持一项临床研究，比较非侵入性设备ShuntCheck和当前侵入性黄金标准--放射性核素测试在诊断成人正常压力脑积水(NPH)患者分流功能故障中的准确性，这项建议解决了医院或门诊使用的实时定量确定分流功能的诊断工具的需求。这项研究的结果可能支持对目前用于管理有症状的NPH患者的标准诊断途径的重要改变。

DESCRIPTION (provided by applicant): This Phase 1 SBIR will develop a non-invasive alternative to radionuclide shunt patency testing for evaluating Normal Pressure Hydrocephalus (NPH) patients with suspected shunt malfunction. Hydrocephalus is a disorder of cerebrospinal fluid dynamics that is commonly treated by placing a shunt that carries excess fluid from the brain to the abdomen. While this treatment is generally successful, shunts inevitably fail, usually by obstruction. The clinical signs of shunt obstruction, the gradual decline into dementia-like symptoms, make shunt failure challenging to diagnose. Suspected obstruction in NPH patients is typically investigated using an invasive radionuclide shunt patency study. There are currently no non-invasive, non- radiological techniques for the early diagnosis of shunt obstruction. NeuroDx Development (NeuroDx) is developing a tool, ShuntCheck, for rapid, non-invasive measurement of CSF flow through a VP shunt by transcutaneous temperature detection as cooled CSF moves through the shunt tubing. The resulting hand-held device is a convenient method for rapidly determining shunt function. Key to translating this device into the NPH clinic is the completion of a clinical validation study to compare the device's diagnostic sensitivity and specificity to radionuclide testing. The goal of this Phase 1 project is to complete a 25 patient clinical study of ShuntCheck compared to radionuclide. In Phase 2, we anticipate conducting a multi-center outcomes study of ShuntCheck as a shunt patency test for NPH patients. This study will be conducted as a pivotal trial and will be used to support expanded labeling for ShuntCheck. The result of this study could be an important change in the diagnostic algorithm currently used to manage symptomatic NPH patients. Given the need for a non-invasive method to accurately diagnose shunt failure, the potential savings over alternative methods and the potential for improved patient outcomes, the data from this study will support a product which is commercially viable and extremely important. PUBLIC HEALTH RELEVANCE: This proposal addresses the need for diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitatively determine shunt function by supporting a clinical study comparing the accuracy of a non-invasive device, ShuntCheck, to the current invasive gold standard, radionuclide testing, in diagnosing shunt malfunction in adult normal pressure hydrocephalus (NPH) patients. The results of this study could support an important change in the standard diagnostic pathway currently used to manage symptomatic NPH patients.