Monodispersed magnetic nanoparticles for improved diagnostic imaging. Phase II: S

单分散磁性纳米颗粒可改善诊断成像。

基本信息

批准号：
8710215
负责人：
Kannan Manjapra Krishnan
金额：
$ 54.85万
依托单位：
LODESPIN LABS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-08-04 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8710215
关键词：
Agreement Angiography Animal Model Animals Anisotropy Cardiac Cardiovascular Diseases Cardiovascular system Cause of Death Cessation of life Chemicals Chronic Kidney Failure Clinical Collaborations Communities Contrast Media Coronary Coronary Angiography Development Diagnosis Diagnostic Imaging Drug Formulations Evaluation Foundations Frequencies Funding Funding Opportunities Future Germany Goals Gold Grant Image Imaging Techniques Imaging technology Ionizing radiation Iron Joint Ventures Joints Kidney Leadership Letters Licensing Life Light Magnetic Resonance Imaging Magnetism Marketing Medical Medical Imaging Methods Mus Patients Performance Pharmaceutical Chemistry Phase Play Positioning Attribute Procedures Process Production Progress Reports Provider Regulatory Pathway Research Resolution Risk Safety Sales Scientist Small Business Technology Transfer Research System Techniques Technology Three-Dimensional Image Time Toxicology Tracer United States United States National Institutes of Health Work X-Ray Computed Tomography base cardiovascular imaging commercialization design disease diagnosis image reconstruction improved in vivo in vivo imaging iron oxide magnetic field material transfer agreement molecular imaging nanoparticle next generation novel particle pre-clinical public health relevance

项目摘要

DESCRIPTION (provided by applicant): In the proposed phase II NIH STTR funding opportunity (PA-12-089), LodeSpin Labs (LSL) is developing a magnetic nanoparticle tracer for use in Magnetic Particle Imaging (MPI), a disruptive new medical imaging technology currently being developed as a safe, effective and quantitative alternative to existing cardiac imaging technologies like CT and MRI. MPI is a promising safer alternative to current CT angiography procedures; it uses safe magnetic fields (no ionizing radiation) and safe iron oxide nanoparticle tracers. Unlike MRI, it offers real-time imaging that is quantitative and has potential for sub-mm spatial resolution. MPI shows tremendous potential as a safe clinical imaging procedure for diagnosis and treatment of cardiovascular disease (#1 cause of deaths in the US), and opens doors to novel molecular imaging applications. However, it remains under development largely due to the unavailability of suitable tracers. While iron oxide nanoparticle tracers exist, having been developed for MRI as well as for iron replacement in CKD patients (Feraheme), LSL's tracer is the first, and only, tracer to be designed specifically for MPI. Furthermore, there is unanimous agreement in the industrial and academic research community developing MPI hardware that LSL tracers provide superior MPI imaging performance, which will enable MPI's clinical and commercial potential. Therefore, LSL has a significant opportunity to be the first provider of high-performing MPI tracers in the emerging pre-clinical MPI market and future clinical market. In Phase II, UW and LSL, in partnership with industrial giants Bruker BioSpin and Philips Medical Systems, will demonstrate real-time in vivo imaging in phantoms and live animals. LSL has further strengthened its team by including Dr. Steven Conolly, as an imaging scientist consultant, and Dr. Julian Simon, as a conjugation and medicinal chemistry consultant. LSL will also pursue pilot toxicology studies that will demonstrate tracer safety to future investors and enable joint ventures that will ultimately fund future regulatory studies. In Phase I our efforts to develop optimized tracers, and strategic partnerships with Philips Medical Systems (Limited Evaluation License) and Dr. Conolly's group at UC-Berkley (Material Transfer Agreement) have positioned the LSL team as pioneers in MPI tracer technology. There is unanimous agreement in the MPI community that LSL tracers outperform any iron oxide formulation currently in the market. Thus, we envision our tracers as truly enabling MPI in achieving its clinical and commercial potential. In Phase II, LSL's immediate goals are to demonstrate our tracer's superior performance in phantom and in vivo imaging, targeting sub-mm resolution (SA1) in both time- and frequency-domain image reconstruction methods, further enhance tracer performance to compete with current standards in x-ray CA procedures (SA2), and assess tracer safety in pilot toxicology studies in mice (SA3).

描述（由申请人提供）：在拟议的第二阶段 NIH STTR 资助机会 (PA-12-089) 中，LodeSpin Labs (LSL) 正在开发一种用于磁粒子成像 (MPI) 的磁性纳米粒子示踪剂，这是一种颠覆性的新型医学成像目前正在开发的技术是 CT 和 MRI 等现有心脏成像技术的安全、有效和定量的替代方案。 MPI 是当前 CT 血管造影手术的一种有前途的更安全的替代方案；它使用安全磁场（无电离辐射）和安全氧化铁纳米颗粒示踪剂。与 MRI 不同，它提供定量的实时成像，并且具有亚毫米空间分辨率的潜力。 MPI 作为诊断和治疗心血管疾病（美国第一大死亡原因）的安全临床成像程序显示出巨大潜力，并为新型分子成像应用打开了大门。然而，由于缺乏合适的示踪剂，它仍在开发中。虽然氧化铁纳米粒子示踪剂已存在，并且已开发用于 MRI 以及 CKD 患者的铁替代 (Feraheme)，但 LSL 的示踪剂是第一个也是唯一一个专为 MPI 设计的示踪剂。此外，开发MPI硬件的工业和学术研究界一致认为LSL示踪剂可提供卓越的MPI成像性能，这将实现MPI的临床和商业潜力。因此，LSL有很大机会成为新兴临床前MPI市场和未来临床市场中高性能MPI示踪剂的第一家提供商。在第二阶段，华盛顿大学和 LSL 将与工业巨头布鲁克 BioSpin 和飞利浦医疗系统合作，展示体模和活体动物的实时体内成像。 LSL 进一步加强了其团队，聘请了 Steven Conolly 博士作为成像科学家顾问，以及 Julian Simon 博士作为结合和药物化学顾问。 LSL 还将开展试点毒理学研究，向未来投资者证明示踪剂的安全性，并建立合资企业，最终为未来的监管研究提供资金。在第一阶段，我们致力于开发优化的示踪剂，并与飞利浦医疗系统（有限评估许可证）和加州大学伯克利分校 Conolly 博士团队（材料转让协议）建立战略合作伙伴关系，使 LSL 团队成为 MPI 示踪剂技术的先驱。 MPI 社区一致认为，LSL 示踪剂的性能优于目前市场上的任何氧化铁制剂。因此，我们设想我们的示踪剂能够真正帮助 MPI 实现其临床和商业潜力。在第二阶段，LSL的近期目标是展示我们的示踪剂在体模和活体成像中的卓越性能，以时域和频域图像重建方法中的亚毫米分辨率（SA1）为目标，进一步增强示踪剂性能以与当前标准竞争X 射线 CA 程序 (SA2)，并评估小鼠试验毒理学研究中示踪剂的安全性 (SA3)。