A Portable PET Insert System for Simultaneous TOF-PET and MR Brain Imaging

用于同步 TOF-PET 和 MR 脑成像的便携式 PET 插入系统

• 批准号: 10546138
• 负责人: Chenming Chang
• 金额: $ 110.7万
• 依托单位: PETCOIL, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-07 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10546138
• 关键词: Address; Alzheimer' s Disease; Brain; Brain Neoplasms; Brain imaging; Clinical; Clinical Research; Coiled Bodies; Collaborations; Computer software; Data; Devices; Diagnosis; Disease; Dose; Electronics; Ensure; Epilepsy; Goals; Head; Human; Hybrids; Image; Imaging technology; Industry; Institution; Lesion; Magnetic Resonance Imaging; Measures; Medical Imaging; Mental Depression; Mental disorders; Neurofibrillary Tangles; Neurologic; Noise; Organ; Outcome; Patients; Performance; Phase; Photons; Physicians; Pilot Projects; Positron-Emission Tomography; Radiation exposure; Radioactive; Research; Resolution; Scanning; Severity of illness; Signal Transduction; Structure; System; Technology; Time; United States; Universities; Validation; Visualization; X-Ray Computed Tomography; anatomic imaging; base; clinical imaging; commercialization; cost; design; design verification; detector; experience; first-in-human; flexibility; human data; human study; hyperphosphorylated tau; imaging capabilities; imaging modality; imaging study; imaging system; nervous system disorder; portability; preservation; progression marker; prototype; radio frequency; radiologist; scale up

1 Project Summary 2 3 Neurological and mental health disorders cost the United States more than 800 billion each year. Acquiring both 4 PET and MRI images is critical in characterizing conditions such as brain tumors, epilepsy, Alzheimer’s disease, 5 and depression. Today, most patients must undergo two separate studies on PET/CT and MRI systems to 6 acquire PET and MRI data, which is inconvenient for both the patient and referring physician and leads to 7 software-based image fusion error, extra radiation exposure from the CT scan, and typically weeks of delay to 8 acquire both pieces of information necessary to make informed decisions about the disease treatment. Hybrid 9 PET/MRI can acquire PET and MRI studies simultaneously, avoiding the stated issues with two separate studies. 10 Unfortunately, the access to PET/MRI is limited by the high cost of the commercial permanently-integrated 11 PET+MRI systems, which is about $5M for purchasing the system plus a $1.5-2M room renovation cost. Today, 12 only about 50 integrated PET/MRI systems are installed in the US compared to 13,500 installed MRI systems. 13 Moreover, current whole-body PET/CT and PET/MRI systems are limited in spatial resolution and photon 14 sensitivity achievable for brain imaging. To address these needs, PETcoil is developing a portable TOF-PET 15 system that can be inserted into (and removed from) any MRI system to lower the cost to achieve simultaneous 16 PET/MR brain imaging by up to 10-fold compared to procuring a permanently-integrated PET/MRI system. It can 17 be used with multiple MRI systems for different applications (e.g., clinical and research) or employed as a 18 portable stand-alone system to provide flexible PET imaging capability. Moreover, the PET system will achieve 19 over 3 times higher photon sensitivity and over 4 times finer volumetric spatial resolution compared to state-of- 20 the-art PET/MRI systems. In Phase I, we have developed a partial PET ring of detector modules based on a 21 scalable detector module design and verified its performance and MRI compatibility. In Phase II, we will continue 22 our collaboration with Dr. Craig Levin at Stanford University to develop the full PET insert system (Aim 1), validate 23 the performance and MRI compatibility of the PET insert (Aim 2), and conduct first-in-human pilot studies to 24 validate the clinical image quality acquired with the PET insert (Aim 3). The outcome of Phase II will be the first 25 commercial prototype radiofrequency (RF)-penetrable TOF-PET insert for simultaneous PET/MR and validation 26 of its image quality in clinical pilot studies of neurological disorders. The data collected in the first-in-human study 27 will form the basis of the 510(k) submission of the device. We contend that the proposed PET insert, which allows 28 institutions with at least one MRI system to achieve PET/MRI with up to 10-fold lower cost and superior PET 29 image quality compared to current permanently-integrated PET/MR products offered on the market, will facilitate 30 dissemination of and access to PET/MRI for studying neurological and mental health disorders.

1项目概要 2 神经和精神健康疾病每年花费美国超过8000亿美元。获取两者 4 PET和MRI图像在表征脑肿瘤、癫痫、阿尔茨海默病等疾病方面至关重要， 5、抑郁症今天，大多数患者必须接受PET/CT和MRI系统的两项单独研究， 6采集PET和MRI数据，这对患者和转诊医生都不方便，并导致 7基于软件的图像融合错误，来自CT扫描的额外辐射暴露，以及通常延迟数周， 8.获得做出关于疾病治疗的明智决定所需的两条信息。混合 9 PET/MRI可以同时采集PET和MRI研究，避免了两个单独研究的问题。 10不幸的是，PET/MRI的使用受到商业永久集成的高成本的限制。 11台PET+MRI系统，购买该系统约需500万美元，加上150 - 200万美元的房间装修费用。今天， 12美国仅安装了约50个集成PET/MRI系统，而安装的MRI系统为13，500个。 13此外，当前的全身PET/CT和PET/MRI系统在空间分辨率和光子分辨率方面受到限制。 14灵敏度可达到脑成像。为了满足这些需求，PETcoil正在开发便携式TOF-PET 15系统，可以插入到任何MRI系统中（和从任何MRI系统中移除），以降低成本，实现同时 16 PET/MR脑部成像比采购永久集成的PET/MRI系统高出10倍。它可以 17可以与用于不同应用的多个MRI系统一起使用（例如，临床和研究）或作为 18便携式独立系统，提供灵活的PET成像能力。此外，PET系统将实现 19与现有技术相比，光子灵敏度提高3倍以上，体积空间分辨率提高4倍以上。 20个最先进的PET/MRI系统。在第一阶段，我们已经开发了一个部分PET环的探测器模块的基础上， 设计了21个可扩展探测器模块，并验证了其性能和MRI兼容性。在第二阶段，我们将继续 22我们与斯坦福大学的克雷格莱文博士合作开发完整的PET插入系统（目标1），验证 23 PET衬垫的性能和MRI兼容性（目标2），并进行首次人体试验研究， 24确认使用PET插入物采集的临床图像质量（目标3）。第二阶段的成果将是第一个 25个商业原型射频（RF）可穿透TOF-PET插件，用于同步PET/MR和验证 26其图像质量在神经系统疾病的临床试点研究。首次人体研究中收集的数据 27将构成器械510（k）提交的基础。我们认为，拟议的PET插入，这使得 28家机构拥有至少一套MRI系统，实现成本低10倍的PET/MRI和上级PET 与目前市场上提供的永久集成PET/MR产品相比， 30传播和获得PET/MRI，以研究神经和精神健康疾病。