Commercialization of a CT-based Technique for BOS Assessment

基于 CT 的 BOS 评估技术的商业化

• 批准号: 9763983
• 负责人: Craig J Galban
• 金额: $ 55.36万
• 依托单位: IMBIO, LLC
• 依托单位国家: 美国
• 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/9763983
• 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

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.

接受过异基因造血干细胞移植（allo-HSCT）或肺移植的患者 移植常常发生肺部并发症。这些移植受者通常会出现 可能危及生命的情况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 生活质量和提高总生存率，因为一旦BOS成为 在肺组织中建立。BOS的治疗仍然有限，因为其他肺部并发症 具有与BOS类似的症状，如感染，是普遍的，并最终延误诊断。 临床使用PRM技术，其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。为此 有前途的技术进入常规临床使用的移植受体的商业 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 数据和适用于该患者人群的PRM技术。在这项赠款工作中，我们建议 通过密歇根大学（UM）和Imbio，LLC之间的密切合作关系实现这一目标 investigators.因此，本快速通道提案的具体目标将开发商业PRM 软件应用程序，包括FDA 510（k）所需的产品测试和数据采集 使用配对的CT数据和HSCT以及肺移植受体信息的应用。