POINT-OF-CARE BREATH TEST FOR DISEASES

疾病护理点呼吸测试

• 批准号: 7883028
• 负责人: Michael Phillips
• 金额: $ 10.25万
• 依托单位: MENSSANA RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-10 至 2011-05-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7883028
• 关键词: Acoustics; Air; Algorithms; Alveolar; Biological Assay; Biological Markers; Biopsy; Breast; Breast Cancer Detection; Breath Tests; Cancer Etiology; Capital; Cessation of life; Clinical; Collection; Computers; Data; Detection; Devices; Diagnosis; Diagnostic; Digital Mammography; Disease; Film; Fright; Gas Chromatography; Gases; Heart Transplantation; Helium; Image; Internet; Laboratories; Lung; Mails; Malignant Neoplasms; Malignant neoplasm of lung; Mammography; Marketing; Mass Spectrum Analysis; Multi-Institutional Clinical Trial; National Cancer Institute; Operating System; Outcome; Pain; Painless; Patients; Phase; Pilot Projects; Point-of-Care Systems; Procedures; Pulmonary Tuberculosis; Radiation; Reporting; Risk; Role; Sampling; Screening procedure; Solutions; Surface; System; Technology; Testing; Training; United States Food and Drug Administration; Woman; base; clinical research site; cost; detector; hazard; high risk; instrument; instrumentation; malignant breast neoplasm; point of care; public health relevance; response; tool; user-friendly; validation studies; volatile organic compound

DESCRIPTION (provided by applicant): Background: An advanced breathalyzer system has been developed to collect and analyze volatile organic compounds (VOCs) in alveolar breath in picomolar concentrations (parts per trillion). This technology has made it possible to identify breath biomarkers of diseases including lung cancer, breast cancer, and pulmonary tuberculosis. The problem: These tests employ laboratory-based technology that is slow and expensive, requiring highly trained staff and costly instrumentation. A new solution: The Remote Diagnosis System (RDS): The RDS is a rapid and cost-effective system for point-of-care breath diagnostics. It employs a portable Breathscanner that collects, concentrates, and analyzes breath biomarkers. Data are uploaded via the internet to a central computer that interprets the data with a diagnostic algorithm, and transmits a report to the user by e-mail. Advantages of the RDS: 7 Patient-friendly - breath testing is intrinsically safe, painless and non-invasive 7 User-friendly - clinical staff can be rapidly trained to operate the RDS 7 Convenient - the RDS operates anywhere, in a small footprint of table-top space 7 Rapid response - breath samples are analyzed and interpreted in minutes at the point-of-care 7Cost-effective - low capital cost of instrumentation, compared to laboratory assays 7 Safe - the RDS instrument employs non-inflammable helium carrier gas A new application of the RDS- Detection of breast cancer: In a pilot study, a laboratory-based breath test employing accurately identified women with breast cancer. In a recent validation study, the breath test identified breast cancer with accuracy superior to imaging with film or digital mammography. A point-of-care breath test yielded similar results, demonstrating the feasibility of detecting breast cancer with the RDS. Clinical role of the RDS: Breath testing is an ancillary procedure that is complementary to, not a substitute for, breast imaging or biopsy. The RDS could dramatically reduce utilization of these tests by identifying high-risk patients who require further testing, while safely excluding low-risk patients who do not. Short-term objectives: In Phase I, we will evaluate the RDS for: a. technical feasibility at three geographically diverse academic clinical sites, and b. clinical value in a pilot study of women with breast cancer versus cancer-free controls Long-term objectives: a. Scientific: Validate the RDS as a new tool for detection of breast cancer. b. Regulatory: Obtain FDA approval of the RDS for clinical use. c. Commercial: Market the RDS in the USA and overseas. PUBLIC HEALTH RELEVANCE: The Remote Diagnosis System (RDS) is a rapid and cost-effective system for point-of-care breath diagnostics. It employs a portable Breathscanner that collects, concentrates, and analyzes breath biomarkers of disease. Data are uploaded via the internet to a central computer which then transmits a report to the user by e-mail. We will evaluate the RDS at three clinical sites for technical feasibility, and for detection of women with breast cancer.

描述（由申请人提供）： 背景：已开发出一种先进的呼吸分析仪系统，用于收集和分析肺泡呼吸中皮摩尔浓度（万亿分之一）的挥发性有机化合物 (VOC)。这项技术使得识别肺癌、乳腺癌和肺结核等疾病的呼吸生物标志物成为可能。 问题是：这些测试采用基于实验室的技术，速度慢且昂贵，需要训练有素的工作人员和昂贵的仪器。 新的解决方案：远程诊断系统 (RDS)：RDS 是一种快速且经济高效的床旁呼吸诊断系统。它采用便携式呼吸扫描仪来收集、集中和分析呼吸生物标记物。数据通过互联网上传到中央计算机，中央计算机使用诊断算法解释数据，并通过电子邮件将报告发送给用户。 RDS 的优点： 7 患者友好 - 呼吸测试本质上是安全、无痛和非侵入性的 7 用户友好 - 临床工作人员可以快速接受培训以操作 RDS 7 方便 - RDS 可在任何地方操作，只需占用很小的桌子- 顶部空间 7 快速响应 - 在护理点几分钟内即可分析和解释呼吸样本 7 成本效益 - 与实验室测定相比，仪器的资本成本较低 7 安全 - RDS 仪器采用不易燃氦气载气 RDS 的新应用 - 乳腺癌检测：在一项试点研究中，采用基于实验室的呼气测试准确识别患有乳腺癌的女性。在最近的一项验证研究中，呼气测试识别乳腺癌的准确性优于胶片或数字乳房X光检查。护理点呼气测试也得出了类似的结果，证明了使用 RDS 检测乳腺癌的可行性。 RDS 的临床作用：呼气测试是一种辅助程序，是乳腺成像或活检的补充，而不是替代。 RDS 可以识别需要进一步检测的高风险患者，同时安全地排除不需要的低风险患者，从而显着减少这些检测的使用。短期目标：在第一阶段，我们将评估 RDS 的以下目标：三个不同地理位置的学术临床中心的技术可行性，以及 b．乳腺癌女性与无癌对照女性试点研究的临床价值 长期目标：科学：验证 RDS 作为检测乳腺癌的新工具。 b.监管：获得 FDA 批准 RDS 进行临床使用。 c.商业：在美国和海外销售 RDS。 公共健康相关性：远程诊断系统 (RDS) 是一种快速且经济高效的护理点呼吸诊断系统。它采用便携式呼吸扫描仪来收集、集中和分析疾病的呼吸生物标志物。数据通过互联网上传到中央计算机，然后中央计算机通过电子邮件将报告传输给用户。我们将在三个临床中心评估 RDS 的技术可行性以及对患有乳腺癌的女性的检测。