Alveoscopy, Endoscopic Confocal Microscopy and Lung Rejection, Parenchymal Lung Diseases in Vivo

Study Overview
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Brief Summary
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Lung transplantation is indicated when end-stage lung diseases no longer respond to available standard therapy, making life expectancy short and associated with disability. Acute and chronic rejection are common complications following transplantation, indicating screening bronchoscopies and transbronchial biopsies at three month intervals the first two years, in addition to clinically indicated procedures when rejection or infection is suspected. Transbronchial biopsies carry associated risks (bleeding, pneumothorax). Chronic rejection is characterized by progressive obliteration of distal airways (Bronchiolitis Obliterans-BO-). BO requires open lung biopsy for diagnosis. Alternatively, a clinical surrogate (Bronchiolitis Obliterans Syndrome), characterized by decline in Forced Expired Volume in 1 second not explained by acute rejection or infection is used for diagnosis. The new technique of confocal endo-microscopy enables sub-surface visualization of tissue in vivo during bronchoscopic procedures using a probe-based confocal microscope, integrated to a standard endoscope. Bronchiolar and alveolar structures can be visualized at a cellular and nuclear level, and these images can be saved and reviewed. This new technology could potentially identify acute and chronic rejection, thus offering and alternative to transbronchial biopsies. We expect to describe a new alternative to diagnose acute and chronic rejection using confocal microscopy images obtained endoscopically, obviating complications of transbronchial biopsies. Endoscopic confocal endomicroscopy can detect and classify common bronchiolar and alveolar pathological conditions in real time. Specifically, we hypothesize that confocal endomicroscopy images of bronchiolar and alveolar structures during standard bronchoscopy could help to recognize and classify the presence/absence of acute rejection and/or bronchiolitis obliterans syndrome in lung transplant recipients. This technology could also identify the histological characteristics lung diseases such as interstitial, obstructive or vascular end stage lung diseases, and thus lead to more efficient, safer and more accurate diagnosis of these lung conditions during routine bronchoscopies.

Official Title
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The Role Of Endoscopic Alveoscopy by Confocal Endomicroscopy in Diagnosing Acute and Chronic Rejection in Lung Transplant Recipients, Diagnosis of End Stage Lung Disease, and Other Pulmonary Pathologies in Vivo

Conditions
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Lung Transplant

Intervention / Treatment
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* Other: Confocal imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 years Any patient undergoing surveillance or clinically indicated bronchoscopies during or after lung transplantation Any patient undergoing bronchoscopy prior lung transplant Exclusion Criteria: Unwilling to consent Unable to safely tolerate a bronchoscopic procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung transplant<br>All lung transplant patients presenting for screening/surveillance and diagnostic bronchoscopies at Mayo Clinic Florida are eligible for participation. | Other: Confocal imaging<br>* At the time of the standard of care bronchoscopy, confocal images will be obtained from each consented patient.<br>* Other names: Cellvizio-Lung system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine in an unblinded study, the key image features of acute lung rejection and chronic lung rejection (BOS), and estimate which morphologic features best distinguish these conditions. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the initial sensitivity and specificity of confocal imaging for the classification of acute lung rejection among lung transplant recipients. |  | One year | 
| To develop a library of confocal images with the most optimal confocal imaging characteristics of other lung pathologies requiring lung transplantation. |  | One year | 
| To determine the inter-examiner differences and learning curve for accurate detection of acute rejection as well as the confocal images of other lung pathologies. |  | One year | 
| To determine in a unblinded pilot study, the key image features of chronic lung rejection as defined by the Bronchiolitis Obliterans Syndrome (BOS), and estimate which morphologic features best distinguish this conditions. |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung rejection