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）第一阶段项目提出开发一种设备，允许在几乎任何医院或诊所现场生产PET（正电子发射断层扫描）同位素。 新兴的同位素如11 C、13 N和15 O具有重要的医疗用途，但半衰期很短（分别为20、10和2分钟）。这就排除了它们在大多数医院和诊所的使用，因为那里不存在现场生产能力。事实上，即使是最现代化的回旋加速器的尺寸和质量也阻止了它们在大多数医疗设施中的安装。该装置利用了氘和氦-3之间核聚变反应的能量增益，使高能质子（10 MeV）的产生与一个简单的，轻量级的加速器操作只有几百千伏。这项工作建立在现有的原型上，其中高度聚焦的氘束撞击氦-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13 N标记NH3的有效母体材料，可有效诊断心脏病。可行性证明将通过实现3 x 1011质子/s的质子产生速率和0.5 mCi的13 N的合成来建立。该项目更广泛的影响/商业潜力将通过增加对已经广泛使用的PET同位素18 F的访问来实现，更重要的是，对寿命较短的同位素11 C，13 N和15 O的访问的转型性增加。这些同位素已被证明是研究医院的强大工具，但由于无法获得，大多数医生和患者无法获得，特别是在疾病的早期阶段，它们将产生最有益的影响。改善PET同位素的现场生产将对人类健康产生重大的积极影响。此外，这项创新具有巨大的市场潜力。PET正迅速进入主流医疗保健领域，新同位素和新程序的广泛使用将进一步推动这一增长。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