Targeted Nanoparticles of Bismuth Organo Complexes for Spectral CT Imaging of Cor

用于 Cor 光谱 CT 成像的铋有机配合物靶向纳米颗粒

基本信息

批准号：
8253172
负责人：
Gregory M Lanza
金额：
$ 19.98万
依托单位：
OCEAN NANOTECH, LLC
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-07-01 至 2014-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8253172
关键词：
Accident and Emergency department Acute Anatomy Animals Arkansas Attenuated Beds Biodistribution Bismuth Calcium Canis familiaris Cardiac Cardiac Catheterization Procedures Cardiovascular system Chest Pain Clinical Collaborations Complement Complex Coronary Coronary heart disease Coupling Decision Making Deposition Development Diagnosis Disease Drug Formulations Drug Kinetics Epitopes Etiology Fibrin Fibrinogen Floor Goals Healthcare Heart Diseases Home environment Hospitals Human Human Development Image Immune Individual Life Ligands Lung Materials Testing Medical Modeling Musculoskeletal Myocardial Nanotechnology Oceans Oryctolagus cuniculus Outcome Patient Transfer Patients Peptides Pharmacodynamics Phase Predictive Value Preparation Procedures Process Production Proteins Recording of previous events Relative (related person)Research Research Personnel Risk Rupture Safety Sterility Stress Tests Technology Telemetry Thrombosis Thrombus Toxic effect Toxicity Tests Universities Validation Washington X-Ray Computed Tomography attenuation cost evaluation/testing follow-up gastrointestinal heart imaging improved in vivo innovation molecular imaging nanomaterials nanoparticle novel prototype scale up stability testing

项目摘要

DESCRIPTION (provided by applicant): Chest pain in patients presenting to the emergency department (ED) present a clinical dilemma: transfer for emergent coronary revascularization, admit overnight for cardiac telemetry and stress testing, or discharge home with medical follow-up. In this proposal, we hypothesize that a novel thrombus-specific Spectral Computed Tomography (Multicolored CT) nanoparticle (i.e., NanoK) approach for direct rapid assessment of coronary disease in the ED could help resolve this clinical dilemma. This project, which is led by Ocean NanoTech in collaboration with Washington University, will complete development of a GLP-/GMP-ready 1- fibrin NanoK product candidate suitably advanced for GLP stability and toxicity testing to support an FDA IND. This NanoK platform technology offers unique benefits for diagnosis and treatment of acute coronary disease that could improve healthcare outcomes and reduce costs. PUBLIC HEALTH RELEVANCE: Chest pain in patients presenting to the emergency department (ED) present a clinical dilemma: transfer for emergent coronary revascularization, admit overnight for cardiac telemetry and stress testing, or discharge home with medical follow-up. While the emergent need for cardiac catheterization is self evident from the presentation of some individuals, the determination of whether to admit or discharge a patient with an equivocal history and physical is often problematic. In lieu of missing a critical cardiac diagnosis, patients are admitted for myocardial evaluation and stress testing, which is inconvenient, costly and unnecessary in the majority of cases. In this proposal, we hypothesize that a novel thrombus-specific Spectral Computed Tomography (Multicolored CT) nanoparticle (i.e., NanoK) approach for direct rapid assessment of coronary disease in the ED could help resolve this clinical dilemma. This project describes the demonstration of the prototype concept in Phase 1 and the development, demonstration, and characterization of the clinical product candidate in Phase II. The overarching goal of this project, which is led by Ocean NanoTech in collaboration with Washington University, will be to complete development of a GLP- /GMP-ready 1-fibrin NanoK product candidate suitably advanced for GLP stability and toxicity testing to support an FDA IND. This NanoK platform technology offers unique benefits for diagnosis and treatment of acute coronary disease that could improve healthcare outcomes and reduce costs.

描述（由申请人提供）：到急诊室 (ED) 就诊的患者出现胸痛，面临临床困境：转院进行紧急冠状动脉血运重建、入院过夜进行心脏遥测和压力测试，或者出院回家进行医疗随访。在本提案中，我们假设一种用于直接快速评估急诊科冠心病的新型血栓特异性光谱计算机断层扫描（彩色 CT）纳米颗粒（即 NanoK）方法可以帮助解决这一临床困境。该项目由 Ocean NanoTech 与华盛顿大学合作领导，将完成 GLP-/GMP 就绪的 1-纤维蛋白 NanoK 候选产品的开发，该候选产品将适当推进 GLP 稳定性和毒性测试，以支持 FDA IND。该 NanoK 平台技术为急性冠心病的诊断和治疗提供了独特的优势，可以改善医疗保健结果并降低成本。公共卫生相关性：到急诊科 (ED) 就诊的胸痛患者面临着一个临床困境：转院进行紧急冠状动脉血运重建、入院过夜进行心脏遥测和压力测试，或者出院回家进行医疗随访。虽然从一些人的表现来看，心导管插入术的迫切需要是不言而喻的，但确定是否让病史和体检不明确的患者入院或出院往往是有问题的。为了避免错过重要的心脏诊断，患者入院进行心肌评估和压力测试，这在大多数情况下不方便、昂贵且不必要。在本提案中，我们假设一种用于直接快速评估急诊科冠心病的新型血栓特异性光谱计算机断层扫描（彩色 CT）纳米颗粒（即 NanoK）方法可以帮助解决这一临床困境。该项目描述了第一阶段原型概念的演示以及第二阶段临床候选产品的开发、演示和表征。该项目由 Ocean NanoTech 与华盛顿大学合作领导，其总体目标是完成 GLP-/GMP 就绪 1-纤维蛋白 NanoK 候选产品的开发，该候选产品经过适当改进，可进行 GLP 稳定性和毒性测试，以支持 FDA IND。这种 NanoK 平台技术为急性冠心病的诊断和治疗提供了独特的优势，可以改善医疗保健结果并降低成本。