Optic/Ultrasonic Hybrid Molecular Imaging Overlay

描述（由申请人提供）：分子成像是改善诊断、治疗选择和治疗监测的关键。PI和该资助的团队之前已经开发并商业化了基础光学技术（开发了第一个体内荧光素酶成像，PI共同创立了Xenogen，并开发了T Stat.，第一个FDA批准的用于组织缺乏足够血流的监测器）。主要的成像公司（西门子、菲利普斯、通用电气等）现在也有分子成像项目。然而，这些技术中的大多数都是昂贵的。Xenogen IVIS成像系统的零售价为80万美元，而GE/ART时间分辨SoftScan。乳房成像仪预计将花费数百万美元。目前缺乏的是一种简单、价格合理（20，000 - 50，000美元）的分子成像设备，可以很容易地纳入当前的临床实践。这样的设备将允许分子成像的临床扩展。在这个快速通道R43/R44中，经验丰富的商业团队将开发一种具有光谱覆盖的真实的时间组合便携式办公室超声，允许生化测量（缺血检测，脂质/水含量）覆盖在已建立和接受的商业超声图像上。直接应用的领域是局部缺血和癌症的成像。对于这个提议，我们将研究器官缺血的成像，例如新生儿坏死性小肠结肠炎的检测，这是一种导致5%早产儿严重疾病、发育迟缓、败血症和/或死亡的疾病。我们预计这种用于局部缺血和癌症的设备的市场每年可以合理地达到数亿美元。我们建议利用我们现有的知识和合作，在这个快速通道R43/R44的建议，使和开发和试点测试的组合超声成像仪与光谱覆盖。在1年的R43中，我们将根据FDA标准构建可制造的系统，然后证明试点可行性（NEC患者与匹配对照组相比）。在3年的R44中，该设备将减少生产，提交给FDA，并在50名患者中进行I期/II期临床试验。如果成功，将推出一种商业设备，这是该团队之前两次实现的道路。该装置将具有广泛的适用性，包括与其他小组正在开发的分子造影剂一起使用。

DESCRIPTION (provided by applicant): Molecular imaging is key for improved diagnosis, treatment selection, and treatment monitoring. The PI and team of this grant have previously developed and commercialized fundamental optical technologies (developed the first in vivo luciferase imaging, PI co-founded Xenogen, and developed T Stat., the first FDA approved monitor for lack of sufficient blood flow to tissue). Major imaging companies (Siemens, Phillips, GE, and others) now have molecular imaging programs as well. However, most of these technologies are expensive. The Xenogen IVIS imaging system retails for $800,000, while the GE/ART time resolved SoftScan. breast imagers are expected to cost millions of dollars. What is lacking is a simple, reasonably priced ($20,000-$50,000) molecular imaging device that can be readily incorporated into current clinical practice. Such a device would allow clinical expansion of molecular imaging. In this fast track R43/R44, an experienced commercial team will developed a real time combination portable office ultrasound with spectroscopic overlay, allowing biochemical measurements (ischemia detection, lipid/water content) to be overlaid on an established and accepted commercial ultrasound images. Areas with immediate application are the imaging of ischemia and cancer. For this proposal, we will study the imaging of organ ischemia, exemplified by the detection of Neonatal Necrotizing Enterocolitis, a disease the leads to severe illness, retardation, sepsis, and/or death in 5% of premature infants. We expect that the market for such a device in ischemia and cancer could reasonably be in the hundreds of millions of dollars per year. We propose to leverage our existing knowledge and collaborations in this fast track R43/R44 proposal to make and develop and pilot test a combination ultrasound imager with spectroscopic overlay. In a 1year R43, we will build a manufacturable system to FDA standards, and then demonstrate pilot feasibility (patients with NEC, compared to matched controls). In a 3year R44, the device will be reduced to manufacturing, submitted to the FDA, and made available for Phase I/Phase II clinical testing in 50 patients. If successful, a commercial device will be introduced, a path this team has achieved twice before. The device would have wide applicability, including use with molecular contrast agents being developed by other groups.