Optic/Ultrasonic Hybrid Molecular Imaging Overlay

光学/超声混合分子成像叠加

• 批准号: 7407821
• 负责人: David A. Benaron
• 金额: $ 28.38万
• 依托单位: SPECTROS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2010-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7407821
• 关键词: Animals; Area; Binding; Biochemical; Blood flow; Breast; Cessation of life; Clinical; Clinical Data; Collaborations; Color; Computer software; Contrast Media; Data; Data Analyses; Data Collection; Detection; Devices; Diagnosis; Disease; Enrollment; Grant; Human; Hybrids; Image; Imaging Device; Imaging technology; Ischemia; Knowledge; Lipids; Luciferases; Malignant Neoplasms; Marketing; Measurement; Medical; Molecular; Monitor; Necrotizing Enterocolitis; Neonatal; None or Not Applicable; Numbers; Optics; Organ; Patients; Performance; Phase; Phase I/II Trial; Premature Infant; Price; Process; Research; Resolution; Selection for Treatments; Sensitivity and Specificity; Sepsis; Spectrum Analysis; Standards of Weights and Measures; Sterility; System; TStat; Technology; Testing; Time; Tissues; Ultrasonics; Ultrasonography; United States Food and Drug Administration; Water; biomaterial compatibility; cost; design; experience; follow-up; improved; in vivo; molecular imaging; optical imaging; pilot trial; programs; research clinical testing; time use; tumor

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.

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。此项资助的 PI 和团队此前已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.，这是 FDA 批准的第一个用于组织血流不足的监测仪） 。主要成像公司（西门子、飞利浦、GE 等）现在也拥有分子成像项目。然而，这些技术大多数都很昂贵。 Xenogen IVIS 成像系统零售价为 800,000 美元，而 GE/ART 时间分辨 SoftScan。乳房成像仪预计花费数百万美元。所缺乏的是一种简单、价格合理（20,000 美元至 50,000 美元）的分子成像设备，可以轻松融入当前的临床实践。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叠加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）叠加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。对于本提案，我们将研究器官缺血的成像，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% 的早产儿出现严重疾病、发育迟缓、败血​​症和/或死亡。我们预计这种治疗缺血和癌症的设备的市场每年可能达到数亿美元。我们建议利用我们在快速轨道 R43/R44 提案中的现有知识和合作来制造、开发和试点测试具有光谱叠加的组合超声成像仪。在 1 年的 R43 中，我们将按照 FDA 标准构建一个可制造的系统，然后证明试点可行性（NEC 患者与匹配对照相比）。在 3 年 R44 中，该设备将减少生产，提交给 FDA，并可在 50 名患者中进行 I/II 期临床测试。如果成功，将推出商业设备，该团队之前已经实现过两次。该设备将具有广泛的适用性，包括与其他小组开发的分子造影剂一起使用。