Commercialization of a CT-based Technique for BOS Assessment

基于 CT 的 BOS 评估技术的商业化

基本信息

批准号：
10165795
负责人：
Craig J Galban
金额：
$ 45.98万
依托单位：
IMBIO, LLC
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-01 至 2022-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10165795
关键词：
Algorithms Allogenic Bronchiolitis Obliterans Categories Chronic Obstructive Airway Disease Clinical Clinical Data Collaborations Computer software Data Diagnosis Disease Early Diagnosis Environment Europe Evaluation FDA approved Funding Goals Grant Healthcare Systems Hematopoietic Stem Cell Transplantation Hospitals Image Infection Life Lung Lung CAT Scan Lung Transplantation Measurement Medical Device Medicine Michigan Nature Obstructive Lung Diseases Outcome Patient Care Patients Phase Population Process Protocols documentation Publishing Pulmonary Emphysema Quality of life Reproducibility Reproducibility of Results Research Personnel Site Structure of parenchyma of lung Summary Reports Symptoms Syndrome System Techniques Technology Testing Transplant Recipients United States National Institutes of Health Universities X-Ray Computed Tomography acute infection base clinical application clinically relevant commercial application commercialization concept mapping cost data acquisition density design disease diagnosis falls graft vs host disease improved novel patient population post-transplant radiologist response small airways disease software development tool

项目摘要

Patients who have undergone allogenic hematopoietic stem cell transplantation (allo-HSCT) or lung transplantation often develop pulmonary complications. These transplant recipients often develop a potentially life threatening condition known as bronchiolitis obliterans syndrome (BOS), a consequence of graft versus host disease (GVHD). Early diagnosis of BOS is vital for maintaining quality of life and improving overall survival, as few treatment options exist once BOS becomes established in lung tissue. Treatments for BOS remain limited, as other pulmonary complications with similar symptoms to BOS, such as infections, are prevalent and ultimately delay diagnosis. Clinical access to the PRM technology, with its ability to simultaneously delineate specific diseases, would have an immediate and positive impact on this patient population. For this promising technology to enter routine clinical use for transplant recipients a commercial application must be developed, tested and integrated within the clinical workflow using relevant CT data and a PRM technique adapted to this patient population. In this grant effort, we propose to achieve this goal through our close partnership between University of Michigan (UM) and Imbio, LLC investigators. Thus the Specific Aims of this Fast-Track proposal will develop a commercial PRM software application, including product testing and data acquisition necessary for a FDA 510(k) application using paired CT data and HSCT and lung transplant recipient information.

经过同种异性造血干细胞移植（Allo-HSCT）或肺的患者移植通常会出现肺并发症。这些移植接收者通常会发展潜在的威胁生命的疾病称为细支气管炎闭塞综合征（BOS），A 移植与宿主疾病（GVHD）的结果。 BOS的早期诊断对于维持生活质量和改善总体生存的质量，因为BOS变成BOS后，很少有治疗选择在肺组织中建立。 BOS治疗仍然有限，因为其他肺部并发症具有与BOS相似的症状（例如感染）很普遍，并最终延迟诊断。临床访问PRM技术，具有同时划定特定特定的能力疾病将对该患者人群产生直接和积极的影响。为了这有前途的技术可以进入移植接收者的常规临床用途必须使用相关的CT开发，测试和集成应用程序数据和PRM技术适合该患者人群。在这项赠款的努力中，我们建议通过密歇根大学（UM）和Imbio，LLC之间的密切合作伙伴关系实现这一目标调查人员。因此，该快速提案的具体目的将开发出商业PRM 软件应用程序，包括FDA 510（k）所需的产品测试和数据采集使用配对的CT数据以及HSCT和肺移植受体信息的应用。