Optic/Ultrasonic Hybrid Molecular Imaging Overlay

描述（由申请人提供）：分子成像是改进诊断、治疗选择和治疗监测的关键。PI和该基金的团队之前已经开发并商业化了基本的光学技术（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.，这是FDA批准的第一个用于缺乏足够血液流向组织的监视器）。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，大多数这些技术都很昂贵。Xenogen IVIS成像系统零售价为80万美元，而GE/ART时间分辨率软扫描系统零售价为80万美元。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（2万至5万美元）的分子成像设备，可以很容易地应用于当前的临床实践。这样的设备将允许临床分子成像的扩展。在这个快速通道R43/R44中，一个经验丰富的商业团队将开发一种具有光谱覆盖的实时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。具有直接应用价值的领域是缺血和癌症的成像。在这个提议中，我们将研究器官缺血的影像学，以新生儿坏死性小肠结肠炎的检测为例，这种疾病会导致5%的早产儿严重疾病、发育迟缓、败血症和/或死亡。我们预计，这种设备在缺血和癌症方面的市场价值每年将达到数亿美元。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提案中，制造、开发和试点测试具有光谱覆盖的组合超声成像仪。在1年的R43中，我们将建立一个符合FDA标准的可制造系统，然后演示试点可行性（与匹配对照组相比，NEC患者）。在为期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/ II期临床试验。如果成功，商业设备将被引入，这是该团队之前两次实现的途径。该设备将具有广泛的适用性，包括与其他团队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.