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

Completed

• Conditions: Lung Transplant
• Interventions: Other: Confocal imaging

• Registration Number: NCT01033201
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-25
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

1. Age above 18 years
2. Any patient undergoing surveillance or clinically indicated bronchoscopies during or after lung transplantation
3. Any patient undergoing bronchoscopy prior lung transplant

Read More

Exclusion Criteria

1. Unwilling to consent
2. Unable to safely tolerate a bronchoscopic procedure

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung transplant	Confocal imaging	All lung transplant patients presenting for screening/surveillance and diagnostic bronchoscopies at Mayo Clinic Florida are eligible for participation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States