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. ? ? ?
(Opto/Ultrasound Hybrid for Molecular Imaging) - Benaron, David A Public Health Statement This R43/R44 Fast-Track Application seeks to develop, pilot test, and then test in clinical trials for FDA approval a generic molecular imaging device. Molecular imaging is key to improved diagnosis, treatment selection, and treatment monitoring. The leader 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(R), 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(R) 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. In this proposal, an experienced commercial team will developed a real-time combination portable office ultrasound allowing biochemical measurements (ischemia detection, lipid/water content) to be overlaid on an established and accepted commercial ultrasound images, and test in a model example, the lack of sufficient oxygenation to the gut of the premature newborn, a disease called Necrotizing Enterocolitis or NEC. A device able to provide rapid feedback would find us in emergency rooms, delivery rooms, operating rooms, and medical transport, and would be a cost-effective addition to emergency medical care. __________________________ Form SF-424 Public Health Statement
