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

基本信息

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
项目类别：
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&apos 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

项目摘要

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 3 神经和精神健康疾病每年给美国造成超过 8000 亿美元的损失。 4 PET 和 MRI 图像对于表征脑肿瘤、癫痫、阿尔茨海默病、 5 和抑郁症今天，大多数患者必须接受 PET/CT 和 MRI 系统的两项单独的研究。 6 获取 PET 和 MRI 数据，这对患者和转诊医生来说都不方便，并导致 7 基于软件的图像融合错误、CT 扫描的额外辐射暴露以及通常延迟数周的时间 8 获取做出有关混合疾病的明智决策所需的两条信息。 9 PET/MRI 可以同时获取 PET 和 MRI 研究结果，避免了两项单独研究中提到的问题。 10 遗憾的是，由于商业永久集成设备的高成本，PET/MRI 的使用受到限制。 11 台 PET+MRI 系统，购买该系统的费用约为 500 万美元，加上 150 万美元至 200 万美元的房间装修费用。 12 美国仅安装了约 50 套集成 PET/MRI 系统，而 MRI 系统的安装数量为 13,500 套。 13 此外，当前的全身 PET/CT 和 PET/MRI 系统在空间分辨率和光子方面受到限制。 14 大脑成像的灵敏度为了满足这些需求，PETcoil 正在开发便携式 TOF-PET。 15 个系统可以插入（和移除）任何 MRI 系统，以降低实现同步的成本 16 与采购永久集成的 PET/MRI 系统相比，PET/MR 脑成像效果提高了 10 倍。 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个便携式独立系统提供灵活的PET成像能力而且，PET系统将实现。 19 与状态相比，光子灵敏度提高了 3 倍以上，体积空间分辨率提高了 4 倍以上 20 个最先进的 PET/MRI 系统在第一阶段，我们开发了基于 PET 环的探测器模块。 21个可扩展探测器模块设计并验证了其性能和MRI兼容性在第二阶段，我们将继续进行。 22 我们与斯坦福大学的 Craig Levin 博士合作开发完整的 PET 插入系统（目标 1），验证 23 PET 插入物的性能和 MRI 兼容性（目标 2），并进行首次人体试点研究 24 验证使用 PET 插入物获取的临床图像质量（目标 3）将是第一个阶段的结果。 25 个商用原型射频 (RF) 可穿透 TOF-PET 插入物，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中收集的数据是首次在人体研究中。 27 将构成该设备 510(k) 提交的基础。我们认为拟议的 PET 插入物允许。 28家至少拥有一套MRI系统的机构实现PET/MRI，成本降低多达10倍，且PET性能优越 29 与目前市场上提供的永久集成 PET/MR 产品相比，图像质量将有利于 30 传播和使用 PET/MRI 来研究神经系统和精神健康疾病。