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

这个小型企业创新研究(SBIR)第一阶段项目建议开发一种设备，该设备将允许在几乎任何医院或诊所现场生产正电子发射断层扫描(PET)同位素。新兴的同位素，如11C、13N和15O具有显著的医学用途，但半衰期很短(分别为20、10和2分钟)。这排除了它们在大多数没有现场生产能力的医院和诊所使用的可能性。事实上，即使是最现代的回旋加速器，其大小和质量也阻碍了它们在大多数医疗设施中的安装。该装置利用了氢和氦-3之间的核聚变反应所获得的能量，能够用一个简单、轻巧的加速器产生高能质子(10 MeV)，加速器的工作电压只有几百千伏。这项工作建立在一个现有的原型上，在这个原型中，高度聚焦的氢束撞击氦-3气体，产生质子。一个质子捕获装置将安装在含有蒸馏水的原型中，蒸馏水是生产13N标记NH3的有效母质，13N标记NH3对心脏病诊断有效。可行性的证明将通过达到3x1011Proton/S的质子产生率和0.5mCi的13N的合成来建立。该项目的更广泛的影响/商业潜力是通过增加对已经广泛使用的PET同位素18F的获得，以及更重要的是，对寿命较短的同位素11C、13N和15O的获得的变革性增加。这些同位素在研究医院被证明是强大的工具，但由于它们难以获得，大多数医生和患者无法获得，特别是在疾病的早期阶段，因为它们将产生最有益的影响。改善就地生产PET同位素的机会将对人类健康产生重大的积极影响。此外，这一创新具有巨大的市场潜力。PET正在迅速进入主流医疗保健领域，使人们能够广泛获得新的同位素和程序，这将进一步推动这种增长。这项技术的市场最终可能超过每年2亿美元，约占目前每年18F市场的一半

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