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.

接受过同种异体造血干细胞移植（allo-HSCT）或肺移植的患者移植常常会出现肺部并发症。这些移植受者通常会出现可能危及生命的疾病，称为闭塞性细支气管炎综合征 (BOS)，移植物抗宿主病（GVHD）的后果。 BOS 的早期诊断对于维持健康至关重要生活质量并提高总体生存率，因为一旦 BOS 发生，几乎没有治疗选择建立在肺组织中。与其他肺部并发症一样，BOS 的治疗方法仍然有限与 BOS 类似的症状（例如感染）很普遍，并最终延误诊断。 PRM 技术的临床应用，能够同时描绘特定的疾病，将对这一患者群体产生直接和积极的影响。为了这有望进入移植受者常规临床应用的技术必须使用相关 CT 在临床工作流程中开发、测试和集成应用程序数据和适合该患者群体的 PRM 技术。在这项拨款工作中，我们建议通过密歇根大学 (UM) 和 Imbio, LLC 之间的密切合作来实现这一目标调查人员。因此，该快速通道提案的具体目标是开发商业 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 CT 数据以及 HSCT 和肺移植受者信息的应用程序。