Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies
研究概览
简要总结
Bronchoscopy-guided tissue sampling is a central technique in many diseases including diagnosing and staging lung cancers, diagnosing interstitial lung diseases, and acute and/or chronic rejections following lung transplantation. Confocal fluorescence microscopy is a novel technique used for real-time microscopic imaging of proximal and distal airways, microvessels, and inflammatory cells. We hypothesize that confocal fluorescence microscopy images of airways and alveolar structures during standard bronchoscopy could help recognize and classify the presence or absence of acute or chronic rejection in lung transplant recipients.
详细描述
Bronchoscopy-guided tissue sampling is a central technique in many diseases including diagnosing and staging lung cancers, diagnosing interstitial lung diseases, and acute and/or chronic rejections following lung transplantation. Confocal fluorescence microscopy is a novel technique used for in vivo microscopic imaging of proximal and distal airways including bronchial and alveolar walls, microvessels, and inflammatory cells. We hypothesize that confocal fluorescence microscopy images of bronchiolar and alveolar structures during standard bronchoscopy could help recognize and classify the presence or absence of acute or chronic rejection in lung transplant recipients.
The objectives and outcomes of this study are:
- To assess the safety of confocal microscopy imaging in pediatric patients
- To create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of acute and chronic rejections following lung transplantation
- To determine the sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies
- Correlate confocal images to FEV1 results
- Correlate with CXRs and/or CT images
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to be older than six years of age
- •to be undergoing surveillance or clinically indicated bronchoscopies with transbronchial biopsy as part of their routine care
- •to be willing and able to comply with study procedures and provide written informed consent/assent to participate in the study
排除标准
- •to be unwilling to consent
- •to be unable to safely tolerate a bronchoscopic procedure
- •to have any contraindications to short-acting anesthetic agents
- •to have any contraindications to transbronchial biopsies
结局指标
主要结局
Sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies
时间窗: One year
Correlate confocal images to histolopathologic findings of acute rejection, chronic rejection, and no evidence of rejection
次要结局
- Number of participants with adverse events(One year)
- Correlation of confocal images with FEV1 results(One year)
研究者
Levent Midyat
MD
Boston Children's Hospital