Optic/Ultrasonic Hybrid Molecular Imaging Overlay

描述(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和这笔赠款的团队之前已经开发了基本光学技术并将其商业化(开发了第一个体内荧光素酶成像，PI与人共同创立了Xenogen，并开发了第一个FDA批准的针对组织缺乏足够血流的监测仪)。主要的成像公司(西门子、菲利普斯、通用电气等)现在也有分子成像程序。然而，这些技术中的大多数都很昂贵。Xenogen IVIS成像系统的零售价为80万美元，而GE/ART的时间分辨率SoftScan。乳房成像仪预计将花费数百万美元。所缺乏的是一种简单、价格合理(20,000-50,000美元)的分子成像设备，可以很容易地整合到当前的临床实践中。这样的设备将允许分子成像的临床扩展。在这条快速通道R43/R44中，经验丰富的商业团队将开发一种便携式办公室超声与光谱覆盖的实时组合，允许将生化测量(缺血检测、脂肪/水分含量)覆盖在已建立和接受的商业超声图像上。立即应用的领域是缺血和癌症的成像。在这项建议中，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，这种治疗缺血和癌症的设备的市场规模可能合理地达到每年数亿美元。我们建议利用我们现有的知识和在快速通道R43/R44计划中的合作，制造和开发并进行中试测试具有频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，然后证明试点的可行性(NEC患者与匹配的对照组相比)。在3年的R44中，该设备将被简化为制造，提交给FDA，并可用于50名患者的I/II期临床测试。如果成功，将推出一种商业设备，这个团队之前已经两次实现了这条道路。该设备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.