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。

• 批准号: 8522793
• 负责人: Kannan Manjapra Krishnan
• 金额: $ 58.03万
• 依托单位: LODESPIN LABS, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-04 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8522793
• 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; iron oxide; magnetic field; material transfer agreement; molecular imaging; nanoparticle; next generation; novel; particle; pre-clinical; public health relevance

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II阶段NIH STTR资金机会（PA-12-089）中，Lodespin Labs（LSL）正在开发用于磁性粒子成像（MPI）的磁性纳米颗粒示踪剂（MPI），这是一种颠覆性的新型医学成像技术，目前是一种安全，有效，有效，定量的，诸如现有的Cardiac cardiac Imagies和MRI。 MPI是当前CT血管造影程序的有前途的更安全替代方案。它使用安全的磁场（无电离辐射）和安全的氧化铁纳米颗粒示踪剂。与MRI不同，它提供了定量的实时成像，并具有亚MM空间分辨率的潜力。 MPI作为诊断和治疗心血管疾病（美国＃1死亡原因）的安全临床成像程序显示出巨大的潜力，并为新型分子成像应用打开了大门。但是，它仍在开发中，主要是由于合适的示踪剂无法获得。尽管存在氧化铁纳米颗粒示踪剂，但已为MRI开发以及CKD患者（Feraheme）的铁置换术，但LSL的示踪剂是专为MPI设计的第一个，也是唯一的示踪剂。此外，在开发MPI硬件的工业和学术研究界达成了一致的共识，LSL示踪剂提供了出色的MPI成像性能，这将使MPI的临床和商业潜力。因此，LSL有很大的机会成为新兴的临床前MPI市场和未来临床市场中最高表现MPI示踪剂的第一位提供商。在第二阶段，UW和LSL与工业巨头Bruker Biospin和Philips Medical Systems合作，将在幻影和活动物中展示实时的体内成像。 LSL通过包括成像科学顾问的史蒂文·科诺利（Steven Conolly）博士和朱利安·西蒙（Julian Simon）博士（Julian Simon）作为共轭和药物化学顾问，从而进一步加强了团队。 LSL还将进行试点毒理学研究，以证明对未来投资者的示踪剂安全，并使合资企业最终将资助未来的监管研究。在第一阶段，我们为开发优化的示踪剂以及与飞利浦医疗系统（有限评估许可）和UC-Berkley小组（物质转移协议）的战略合作伙伴关系（物质转移协议）的努力已将LSL团队定位为MPI Tracer Technology的先驱。在MPI社区中，LSL示踪剂的表现优于目前市场上的任何氧化铁配方。因此，我们将示踪剂设想为真正使MPI实现其临床和商业潜力。 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).