ISSN 1004-4140
CN 11-3017/P
张博, 邱奥, 夏源, 等. 数字PET产业生态[J]. CT理论与应用研究(中英文), xxxx, x(x): 1-12. DOI: 10.15953/j.ctta.2024.018.
引用本文: 张博, 邱奥, 夏源, 等. 数字PET产业生态[J]. CT理论与应用研究(中英文), xxxx, x(x): 1-12. DOI: 10.15953/j.ctta.2024.018.
ZHANG B, QIU A, XIA Y, et al. All-Digital PET Industry Ecology[J]. CT Theory and Applications, xxxx, x(x): 1-12. DOI: 10.15953/j.ctta.2024.018. (in Chinese).
Citation: ZHANG B, QIU A, XIA Y, et al. All-Digital PET Industry Ecology[J]. CT Theory and Applications, xxxx, x(x): 1-12. DOI: 10.15953/j.ctta.2024.018. (in Chinese).

数字PET产业生态

All-Digital PET Industry Ecology

  • 摘要: 从多电压阈值(MVT)采样方法逐步演化发展出来的数字正电子发射断层成像(PET)创新技术体系,带动了包括关键材料、核心器件、电子学、智能算法和行业标准等在内的多个领域的发展,形成了以硬件模块化、软件智能化为特征的PET产业新生态。2010年全球首台基于MVT方法的数字PET科学仪器成功研制,并展现出明显的空间分辨率优势。借助其探测器模块化的特点,又陆续研制出面向小动物、大动物、灵长类动物和植物的不同孔径、不同视野(FOV)、不同几何架构的数字PET科学仪器,并投入各项科研应用。2015年,全球首台用于人体扫描的数字PET医疗器械样机研制成功。在随后7年里,多款临床数字PET产品陆续完成研制,并投入市场。这些数字PET产品打破过去面向全身扫描的常规固定式系统架构,采用模块化、数字化探测器,构建了部位专用PET、插入式PET、穿戴式PET、质子PET等多种医疗器械。帮助推动PET应用从肿瘤诊断快速拓展至神经系统疾病诊断、心血管疾病诊断、免疫治疗、质子治疗等精准诊疗新领域。数字PET生态的蓬勃发展也带来了产业分工的革新。新型的闪烁晶体材料、新型硅光电倍增器、以及模块化PET探测器正在独立快速的发展,并形成各自的标准化部件或接口。上下游技术同步提升促进了PET全产业链和创新链的发展。随着数字PET技术的迅猛发展,多种技术路线相继被提出,也对相关的产品标准与技术规范的适应性提出新的需求,PET数字化技术要求、数字PET医疗器械注册指导原则等监管体系也进一步得到更新和发展。本文回顾了20余年数字PET在科学仪器、医疗器械、产业链和监管科学方面的动态进展,并对数字PET未来生态发展做出展望。

     

    Abstract: The digital positron emission tomography (PET) innovation technology system, which gradually evolved from the Multi-Voltage Threshold (MVT) sampling method, has driven the development of many fields, including key materials, core devices, electronics, intelligent algorithms, and industry standards, forming a new PET industry ecology characterized by modular hardware and intelligent software. In 2010, the world's first All-Digital PET scientific instrument, based on the MVT method, was successfully developed and showed an obvious spatial resolution advantage. With the modular characteristics of the All-Digital PET’s detector, it has successively developed digital PET scientific instruments with different apertures, different fields of view (FOV), and different geometric structures for small animals, large animals, primates, and plants, and has been put into various scientific research applications. In 2015, the world's first All-Digital PET medical device prototype for human scanning was successfully developed. In the following 7 years, several clinical All-Digital PET products have been developed and put into the market. These All-Digital PET products break the fixed architecture of conventional whole-body scanning in the past and use modular digital detectors to build various medical devices, such as site-dedicated PET systems, plug-in PET components, wearable PET, and proton PET. It has helped promote the rapid expansion of PET applications from tumor diagnosis to new application fields such as nervous system diseases, unexplained fever, and proton precision treatment. The vigorous development of All-Digital PET ecology has also brought innovation to the industrial division of labor. The new scintillation crystal materials, the new silicon photomultiplier (SiPM), and the modular PET detector are developing independently and rapidly, forming their own standardized component or interface. The synchronous progress of upstream and downstream technologies has promoted the development of the entire PET industry chain and innovation chain. With the rapid development of All-Digital PET, the proposal of a variety of PET digital technology routes has also put forward new challenges to industry technical standards and regulatory systems, such as technical requirements for the digitization of PET medical devices and the registration guidelines that have been updated and developed simultaneously. This paper reviewed the dynamic progress of All-Digital PET in scientific instruments, medical devices, the industrial chain, and regulatory science in the past 20 years and looked forward to the future ecological development of All-Digital PET.

     

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