Phase I Amount
$1,532,485
Cyclotron produced [18F]fluorodeooxyglucose (FDG) is widely used in clinical PET/CT for Medicare approved diagnosis and therapy evaluation of many cancers and Alzheimer's. Cyclotron pharmacy distribution centers have kept pace with annual increases in imaging with FDG, whose basis is metabolic (as distinct from anatomical for CT and MRI). However, the demand for 18F radiopharmaceuticals other than FDG has recently been predicted to increase dramatically in the next 2-4 years, expanding the need for by a factor of 5-10. Numerous 99mTc SPECT radiopharmaceuticals, dependent on elution from 99mMo generators (derived from nuclear reactors) have been in use for decades. Today there is a global shortage of reactor produced medical radionuclides due to lengthy shutdowns for repair of the few aging reactors (all non-US). To replace waning radiopharmaceuticals, a concerted effort has been underway for several years to develop 18F radiotracers for PET cardiac, neurological, bone, and other imaging applications. Many of these radiotracers are in clinical trials, and are expected to be approved for reimbursement in the next 3-6 years. Installing more of the predominant 11-18 MeV negative ion cyclotrons utilizing internal Penning ion sources (beam current limited to100-150 microamps) is not the most efficient business model for a large increase in production. A newly conceived and significantly superior approach is to implement larger cyclotrons with injection ion sources that permit beam power a factor of five higher, providing a greater variety of radiopharmaceuticals and larger patient dose volumes. Costs associated with a larger centralized cyclotron pharmacy are much lower than the equivalent 5-6 smaller cyclotrons. This new business model requires availability of targets capable of higher energy dissipation than the applicant's high performance commercial retrofit target systems sold in 2008-2009. The required new technology was established as feasible by the applicant's two Phase 2 SBIR grants completed at the end of 2007, which studied both thermosyphon boiling targets (2-6 kW) and non-boiling recirculating targets (5-20 kW). The goal of the proposed project is to accomplish R&D to implement prototype targets supporting the new business model based on larger centralized cyclotrons, in time to be ready for commercial implementation in mid 2013. Most existing small cyclotrons will have reached full capacity by that time, and the larger cyclotron solution, strategically placed in the midst of existing smaller cyclotrons, is the most efficacious way to address the expected need for increased 18F production.
Public Health Relevance: Alzheimer's Dementia, cardiovascular disease and cancer are increasingly serious public health problems. PET/CT diagnosis and treatment planning has a profound impact on determining the most effective course of patient care. Flourine-18 labeled radiopharmaceuticals are the most important agents for this imaging modality. The overall goal of this project is to significantly increase the availability of fluorine-18 labeled radiopharmaceuticals by developing economical, large scale cyclotron production methods for the fluorine-18 radionuclide.
Public Health Relevance Statement: Alzheimer's Dementia, cardiovascular disease and cancer are increasingly serious public health problems. PET/CT diagnosis and treatment planning has a profound impact on determining the most effective course of patient care. Flourine-18 labeled radiopharmaceuticals are the most important agents for this imaging modality. The overall goal of this project is to significantly increase the availability of fluorine-18 labeled radiopharmaceuticals by developing economical, large scale cyclotron production methods for the fluorine-18 radionuclide.
Project Terms: abstracting; Address; Aging; Alzheimer; Alzheimer disease; Alzheimer sclerosis; Alzheimer syndrome; Alzheimer's; Alzheimer's Disease; Alzheimers Dementia; Alzheimers disease; Amentia; base; Boils; Bone; bone; Bone and Bones; Bones and Bone Tissue; Businesses; Cancers; Cardiac; Cardiovascular Diseases; cardiovascular disorder; Characteristics; Clinical; Clinical Evaluation; clinical investigation; clinical test; Clinical Testing; Clinical Trials; Clinical Trials, Unspecified; commercialization; computational modeling; computational models; computational simulation; computer based models; Computer Simulation; computerized modeling; Computerized Models; computerized simulation; cost; cost effective; Cyclotrons; Dementia; dementia of the Alzheimer type; Dementia, Alzheimer Type; Dementia, Primary Senile Degenerative; Dementia, Senile; design; designing; Development and Research; Diagnosis; Documentation; Dose; experience; F element; Fluorine; Furuncles; Generations; Goals; Grant; H+ element; Health Insurance for Aged and Disabled, Title 18; Health Insurance for Aged, Title 18; health insurance for disabled; Health Insurance for Disabled Title 18; heat exchanger; Heating; Hydrogen Ions; Image; imaging; imaging modality; in silico; Injection of therapeutic agent; Injections; Intellectual Property; ion source; Ions; Label; Laboratories; Legal patent; Magnetic Resonance Imaging; Magnetic Resonance Imaging Scan; malignancy; Malignant Neoplasms; Malignant Tumor; Mathematical Model Simulation; Mathematical Models and Simulations; Mediation; Medical; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; Medical Imaging, Positron Emission Tomography; Medical Imaging, Single Photon Emission Computed Tomography; Medicare; Metabolic; Methods; Methods and Techniques; Methods, Other; model design; Modeling; Models, Computer; Modification; MR Imaging; MR Tomography; MRI; Negotiating; Negotiation; neoplasm/cancer; Neurologic; Neurological; new technology; NMR Imaging; NMR Tomography; Nuclear Magnetic Resonance Imaging; Nuclear Reactors; Ownership; Patents; Patient Care; Patient Care Delivery; Patients; Performance; PET; PET imaging; PET Scan; PET/CT; PET/CT scan; PETSCAN; PETT; Pharmacies; Pharmacy Distributions; Pharmacy facility; Phase; Positron Emission Tomography Scan; Positron-Emission Tomography; primary degenerative dementia; Primary Senile Degenerative Dementia; Procedures; Production; Proton Magnetic Resonance Spectroscopic Imaging; Protons; prototype; Public Health; public health medicine (field); public health relevance; Pump; R & D; R&D; Rad.-PET; radioactive drugs; Radioactive Isotopes; Radioisotopes; radiolabel; Radionuclide Tomography, Single-Photon Emission-Computed; Radionuclides; Radiopharmaceutical Compound; Radiopharmaceuticals; radiotracer; regenerative; repair; repaired; research and development; research clinical testing; Running; SBIR; SBIRS (R43/44); Senescence; senescent; senile dementia of the Alzheimer type; Simulation, Computer based; Site; Small Business Innovation Research; Small Business Innovation Research Grant; Solutions; Source; SPECT; SPECT imaging; System; System, LOINC Axis 4; Techniques; Technology; Testing; Therapy Evaluation; Time; Title 18; Tomography, Emission-Computed, Single-Photon; treatment planning; virtual simulation; Zeugmatography
