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

描述（由申请人提供）：本1期SBIR将开发一种放射性核素分流通畅性试验的无创替代方法，用于评价疑似分流故障的正常压力脑积水（NPH）患者。脑积水是一种脑脊液动力学紊乱，通常通过放置分流器将多余的液体从大脑输送到腹部来治疗。虽然这种治疗通常是成功的，但分流不可避免地失败，通常是由于阻塞。分流阻塞的临床体征，逐渐下降为痴呆样症状，使分流失败的诊断具有挑战性。NPH患者的疑似梗阻通常使用侵入性放射性核素分流通畅性研究进行研究。目前还没有非侵入性、非放射性技术用于分流管阻塞的早期诊断。NeuroDx开发部（NeuroDx）正在开发一种工具ShuntCheck，用于在冷却的CSF通过分流管时，通过经皮温度检测快速、无创地测量通过VP分流管的CSF流量。由此产生的手持设备是一种快速确定分流功能的方便方法。将该设备转化为NPH诊所的关键是完成临床验证研究，以比较该设备对放射性核素检测的诊断灵敏度和特异性。本1期项目的目标是完成ShuntCheck与放射性核素相比的25例患者临床研究。在第2阶段，我们预计将进行一项多中心结局研究，将ShuntCheck作为NPH患者的分流通畅性试验。本研究将作为关键试验进行，并将用于支持ShuntCheck的扩展标签。这项研究的结果可能是目前用于管理症状性NPH患者的诊断算法的重要变化。考虑到需要一种非侵入性方法来准确诊断分流失败，替代方法的潜在节省以及改善患者结局的潜力，本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：本提案通过支持一项临床研究，比较无创器械ShuntCheck与当前有创金标准放射性核素检测在诊断成人正常压力脑积水（NPH）患者分流功能故障方面的准确性，解决了在医院或门诊环境中使用实时工作的诊断工具以定量确定分流功能的需求。这项研究的结果可以支持目前用于管理症状性NPH患者的标准诊断途径的重要变化。

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.