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

NCT01033201 | Completed

• 2 other identifiers: 08-000800ACA00001534
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant

Keywords

Lung rejection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Lung transplant

All lung transplant patients presenting for screening/surveillance and diagnostic bronchoscopies at Mayo Clinic Florida are eligible for participation.

Other: Confocal imaging

Interventions

Confocal imaging OTHER

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

Also known as: AlveoloFlex Confocal Miniprobes, Cellvizio-Lung system

Lung transplant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled to undergo bronchoscopy either before or after lung transplantation.

You may qualify if:

• Age above 18 years
• Any patient undergoing surveillance or clinically indicated bronchoscopies during or after lung transplantation
• Any patient undergoing bronchoscopy prior lung transplant

You may not qualify if:

• Unwilling to consent
• Unable to safely tolerate a bronchoscopic procedure

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (15)

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Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: April 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 26, 2012

Record last verified: 2012-01

Locations

US (1)