Disorder Related to Lung Transplantation
Conditions
Keywords
Acute rejection, Chronic rejection, Confocal microscopy
Brief 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
Interventions
DEVICEAlveoflex Confocal MiniprobeTM
-Alveolar imaging
Sponsors
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies | One year | Correlate confocal images to histolopathologic findings of acute rejection, chronic rejection, and no evidence of rejection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | One year | Monitor for serious adverse events |
| Correlation of confocal images with FEV1 results | One year | Measure the degree of fibrosis/collagen by confocal imaging and compare to FEV1 values |
Countries
United States
Outcome results
None listed