BREATH COLLECTION APPARATUS FOR DIAGNOSIS OF DISEASE

用于疾病诊断的呼吸采集装置

• 批准号: 2644327
• 负责人: Michael Phillips
• 金额: $ 9.02万
• 依托单位: MENSSANA RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 1999-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2644327
• 关键词: blood chemistry; breath composition; breath tests; clinical research; diagnosis design /evaluation; human subject; noninvasive diagnosis; organic chemicals

DESCRIPTION (Adapted from applicant's abstract): The composition of volatile organic compounds (VOCs) in the breath varies with the composition of VOCs circulating in the blood. Therefore, analysis of breath provides a non-invasive probe of blood chemistry. Recent studies with a highly sensitive Series 2.0 breath collecting apparatus (BCA) have shown that VOCs in breath are markers of lung cancer, breast cancer, heart transplant rejection. In order to build on these findings and establish the clinical value of breath testing , it will be necessary to perform the next round of clinical studies. This will require an improved BCA incorporating evolutionary improvements. An improved Generation 3.0 BCA will be constructed, and evaluated in bench top and human studies. The aim is to develop an improved and "user- friendly" BCA which will permit the routine collection and assay of VOCs present in breath in picomolar concentrations. It is planned to employ this BCA in clinical studies to determine the value of breath testing as a non-invasive tool for the detection of disease. FDA approval will be obtained for the BCA, breath tests for disease, and to market the technology for clinical diagnostic applications. PROPOSED COMMERCIAL APPLICATION: Breath testing could provide a new and non-invasive diagnostic tool for monitoring the severity of several diseases, including lung cancer, breast cancer, ischemic heart disease and heart transplant rejection. In practice, the breath collection apparatus (BCA) would be employed by an end user (e.g. a physician or a hospital) to collect breath samples from patients; the samples would them be sent to a central laboratory for analysis by gas chromatography and mass spectroscopy. Automated analysis of the breath chromatogram could then identify the patient's risk for a particular disease, such as lung cancer, and these results would then be communicated to the physician.

描述（改编自申请人的摘要）： 的组成 呼吸中的挥发性有机化合物 (VOC) 随环境的变化而变化 血液中循环的 VOC 成分。 因此，分析 呼吸提供了血液化学的非侵入性探测。 最近的研究 配备高灵敏度 2.0 系列呼吸采集装置 (BCA) 研究表明，呼吸中的挥发性有机化合物是肺癌、乳腺癌的标志物 癌症、心脏移植排斥反应。 为了以这些发现为基础 并确立呼气测试的临床价值 进行下一轮临床研究所必需的。 这将 需要改进的 BCA 结合进化改进。 一个 将构建改进的第 3.0 代 BCA，并在实验室中进行评估 顶级和人类研究。 其目的是开发一种改进的“用户- 友好的”BCA，将允许对 VOC 进行常规收集和分析 以皮摩尔浓度存在于呼吸中。拟聘用 这个BCA在临床研究中确定呼气测试的价值 作为检测疾病的非侵入性工具。 FDA 的批准将 获得 BCA、疾病呼气测试，并将其推向市场 临床诊断应用技术。 拟议的商业应用： 呼气测试可以提供一种新的非侵入性诊断工具 监测多种疾病的严重程度，包括肺癌， 乳腺癌、缺血性心脏病和心脏移植排斥反应。 在实践中，呼吸收集装置（BCA）将被使用 最终用户（例如医生或医院）收集呼吸样本 来自患者；样本将被送往中心实验室 用于气相色谱和质谱分析。自动化 对呼吸色谱图的分析可以识别患者的 特定疾病（例如肺癌）的风险以及这些结果 然后将被传达给医生。