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: 10673126
• 负责人: Chenming Chang
• 金额: $ 102.67万
• 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/10673126
• 关键词: Address; Alzheimer' s Disease; Brain; Brain Neoplasms; Brain imaging; Clinical; Coiled Bodies; Collaborations; Computer software; Data; Devices; Diagnosis; Disease; Dose; Electronics; Ensure; Epilepsy; Goals; Head; Human; Hybrids; Image; Industry; Institution; Lesion; Magnetic Resonance Imaging; Marketing; 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; Specific qualifier value; Structure; System; Technology; Time; United States; Universities; Validation; Visualization; X-Ray Computed Tomography; anatomic imaging; brain magnetic resonance imaging; clinical imaging; commercial prototype; commercialization; cost; design; detector; experience; first-in-human; flexibility; human data; human study; hyperphosphorylated tau; imaging capabilities; imaging modality; 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个项目摘要 2 3神经和心理健康障碍每年使美国超过8000亿。两者都获得 4 PET和MRI图像对于表征脑肿瘤，癫痫，阿尔茨海默氏病，诸如疾病的表征至关重要。 5和抑郁。如今，大多数患者必须对PET/CT和MRI系统进行两项单独的研究 6获取PET和MRI数据，这对患者和参考医师都是不方便的，并导致 7个基于软件的图像融合误差，CT扫描中额外的辐射暴露，通常会延迟数周 8获得了对疾病治疗做出明智决定所必需的两种信息。杂交种 9 PET/MRI可以简单地获取PET和MRI研究，从而避免了两项单独的研究所陈述的问题。 10不幸的是，获得PET/MRI的访问受到商业永久性综合成本的限制 11 PET+MRI系统，购买该系统的价格约为500万美元，再加上15-200万美元的房间翻新成本。今天， 在美国，仅安装了约50个集成的宠物/MRI系统，而安装了13,500个MRI系统。 13此外，当前的全身PET/CT和PET/MRI系统在空间分辨率和照片方面受到限制 14对于大脑成像可以达到的灵敏度。为了满足这些需求，Petcoil正在开发便携式TOF-PET 15可以插入（并从）中删除的系统以降低同时实现成本的系统 与购买永久综合宠物/MRI系统相比，16 PET/MR脑成像最多10倍。它可以 17与多个MRI系统一起用于不同的应用（例如临床和研究）或用作 18便携式独立系统，可提供灵活的宠物成像能力。而且，宠物系统将实现 19倍的光子敏感性高3倍，比最新的体积空间分辨率高4倍 20 The-Art PET/MRI系统。在第一阶段，我们开发了一个基于A的探测器模块的部分PET环 21可扩展检测器模块设计并验证其性能和MRI兼容性。在第二阶段，我们将继续 22我们与斯坦福大学Craig Levin博士的合作开发完整的宠物插入系统（AIM 1），验证 23 PET插入物（AIM 2）的性能和MRI兼容性，并进行首次人类飞行员研究 24验证使用PET插入物获得的临床图像质量（AIM 3）。第二阶段的结果将是第一个 25商业原型射频（RF） - 可渗透的TOF-PET插入物，用于简单PET/MR和验证 它在神经系统疾病的临床试验研究中的图像质量中有26个。第一个人类研究中收集的数据 27将构成设备的510（k）提交的基础。我们认为拟议的宠物插入物，这允许 28个具有至少一个MRI系统的机构，以达到宠物/MRI，成本低超过10倍，宠物上级 29图像质量与当前在市场上提供的永久综合宠物/MR产品相比，将有助于 30用于研究神经和心理健康障碍的PET/MRI的传播和访问权限。