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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-12-31

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.

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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:

1. To assess the safety of confocal microscopy imaging in pediatric patients
2. To create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of acute and chronic rejections following lung transplantation
3. To determine the sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies
4. Correlate confocal images to FEV1 results
5. Correlate with CXRs and/or CT images

Conditions

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Disorder Related to Lung Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Lung transplant recipients

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.

Group Type OTHER

Alveoflex Confocal MiniprobeTM

Intervention Type DEVICE

-Alveolar imaging

Interventions

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Alveoflex Confocal MiniprobeTM

-Alveolar imaging

Intervention Type DEVICE

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No