NCT02395393

Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. To assess the safety of confocal microscopy imaging in pediatric patients 2. To create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of acute and chronic rejections following lung transplantation 3. To determine the sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies 4. Correlate confocal images to FEV1 results 5. Correlate with CXRs and/or CT images

Conditions

• Disorder Related to Lung Transplantation

Interventions

Type	Name	Description
DEVICE	Alveoflex Confocal MiniprobeTM	-Alveolar imaging

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-11-01
• Completion: 2020-12-01
• First posted: 2015-03-23
• Last updated: 2021-09-10

Locations

1 site across 1 country: United States