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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Disorder Related to Lung Transplantation

Intervention / Treatment
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* Device: Alveoflex Confocal MiniprobeTM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lung transplant recipients<br>In patients scheduled for bronchoscopy as part of regular clinical care/diagnostic workup, the investigators will offer the patient concurrent confocal microscopy imaging to be performed during the bronchoscopic procedure. A 1.4mm or 1.9mm diameter Alveoflex Confocal MiniprobeTM (MaunaKea Technologies, France) will be deployed down the working channel of the standard bronchoscope and advanced distally into the alveoli. | Device: Alveoflex Confocal MiniprobeTM<br>* -Alveolar imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies | Correlate confocal images to histolopathologic findings of acute rejection, chronic rejection, and no evidence of rejection | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Monitor for serious adverse events | One year | 
| Correlation of confocal images with FEV1 results | Measure the degree of fibrosis/collagen by confocal imaging and compare to FEV1 values | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute rejection, Chronic rejection, Confocal microscopy