SBIR Phase I: The Fusion Linear Accelerator for Medicine (FLAME): A Transformational Method for Producing PET Isotopes

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This Small Business Innovation Research (SBIR) Phase I project proposes to develop a device that will allow onsite production of PET (Positron Emission Tomography)isotopes at almost any hospital or clinic. Emerging isotopes such as 11C, 13N, and 15O have significant medical utility, but very short half-lives (20, 10, and 2 minutes, respectively). This precludes their use at most hospitals and clinics where no onsite production capability exists. In fact, the size and mass of even the most modern cyclotrons prevents their installation at most medical facilities. The proposed device exploits the energy gain from nuclear fusion reactions between deuterium and helium-3, enabling the creation of high energy protons (10 MeV) with a simple, lightweight accelerator operating at only a few hundred kV. This work builds on an existing prototype in which a highly focused deuteron beam impacts helium-3 gas, creating protons. A proton capture device will be installed in the prototype containing distilled water, an efficient parent material for the production of 13N-labeled NH3, which is effective for diagnosing heart disease. Proof-of-feasibility will be established by attaining a proton production rate of 3 x 1011 protons/s, and the synthesis of 0.5 mCi of 13N.The broader impact/commercial potential of this project is realized as an increase in access to the already widely used PET isotope 18F, and more significantly, a transformational increase in access to the shorter lived isotopes 11C, 13N, and 15O. These isotopes have proven powerful tools at research hospitals, but due to their inaccessibility, are unavailable to most doctors and patients, especially at the early stages of a disease when they would have the most beneficial impact. Improved access to onsite production of PET isotopes would have a significant positive impact on human health. In addition, this innovation has significant market potential. PET is rapidly entering mainstream healthcare, and enabling widespread access to new isotopes and procedures will further fuel this growth. The market for this technology could ultimately exceed $200 million per year, which represents about half of the present annual 18F market