CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 71 enrolled
Drug / intervention
Confocal imagingother
Likely dose
Not stated in record
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Search/NCT01033201
NCT01033201N/ACompleted

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

Mayo Clinic·observational·Posted Dec 16, 2009·Updated Jan 26, 2012

In Brief

An observational study evaluating Confocal imaging for Lung Transplant. Completed, enrolled 71 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLung Transplant
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 16, 2009
Enrollment StartApr 1, 2008
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.5 years ago

Interventions

Confocal imagingother

At the time of the standard of care bronchoscopy, confocal images will be obtained from each consented patient.