The Study Of Probe-Based Confocal Laser Endomicroscopy Of Distal Airways In Diagnostics Of Lung Diseases

Not Applicable

• Conditions: Inflammatory, Interstitial, Rare Lung Diseases
• Interventions: Device: miniprobe Alveoflex

• Registration Number: NCT02006940
• Lead Sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Brief Summary

The study is devoted to the comparative analysis of the data received in patients with lung pathology using new method of probe-based confocal laser endoscopy of distal airways and two reference methods: high resolution computed tomography and morphology.

Detailed Description

A relatively new technology in pulmonary medicine, probe-based confocal laser endomicroscopy of distal airways, which is also called alveoscopy, allows for real-time minimally invasive intraacinar imaging. This method has been developed that special miniprobe can be passed into the distal airway via the working channel of the bronchoscope and provide so called "optical biopsy". The method is based on the natural autofluorescence of pulmonary structures, detecting the elastin scaffold of central and peripheral airways, the structure of alveoli, blood vessels and alveolar macrophages. Taking into account the fact that in vivo endomicroscopy of distal airways is a novel diagnostic technique it needs correlating the obtained data at certain disease with the reference methods for the challenges of our current understanding of interpreting endomicroscopic images. We choose high resolution computed tomography and morphology as such reference methods.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-11-28
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-05
• Last Update Submitted: 2013-12-05
• Study First Posted: 2013-12-10
• Last Update Posted: 2013-12-10
• Primary Completion: 2015-12
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patient Informed Consent;
• patients' fitness;
• the diagnosis of one of the following lung diseases: COPD, pneumonia, solitary nodule, pulmonary sarcoidosis, idiopathic interstitial pneumonia, hypersensitivity pneumonitis, pulmonary vasculitis, pulmonary eosinophilia, hemochromatosis, histiocytosis X, pulmonary lymphangioleiomyomatosis; alveolar proteinosis, other rare lung disease
• high resolution computed tomography scans performed not later than one month before pCLE;
• planned or performed histology

Exclusion Criteria

• Severe respiratory failure,
• pregnancy or breast feeding,
• lung bleeding,
• any acute or chronic disease that may be a contraindication to bronchoscopy,
• any significant blood coagulation disorder,
• any diseases of hematopoietic system,
• alcoholism or toxic addiction,
• taking part in other clinical trials,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alveoflex, in vivo imaging miniprobe	miniprobe Alveoflex	All the patients will be examined using confocal laser endomicroscopy during bronchoscopy with a special minirobe Alveoflex before and after the treatment. Records will be done and analyzed prospectively with the included software for endomicroscopic system.

Primary Outcome Measures

Name	Time	Method
Number of Participants with the Correspondence of pCLE Images to HRCT and Morphologic Data as a Measure of Specificity and Sensitivity of the Method	up to three years	pCLE images will be assessed morphometrically. Such criteria as quantity of alveolar macrophages, quantity of floating intraalveolar substances etc. will be measured using 6-point score, where zero means the absence of the symptom and 5 - the maximal expressiveness. Thickness of interalveolar septum, diameter of microvessels and thickness of elastic fibers will be measured using special tool with the included software for endomicroscopic system. Radiologic signs e.g. low-density areas and consolidation areas will be assessed in Hounsfield Units. Other radiologic signs e.g. ground-glass opacity, crazy paving patterns etc. will be measured by 6-point scale, the same as for pCLE images. Morphological analysis of the lung tissue specimens (received as a result of transbronchial biopsy) will be made according to the structures in pCLE images for 20 fields of view.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	up to two years

Trial Locations

Locations (1)

Federal Research Clinical Center FMBA Russia; 🇷🇺 Moscow, Russian Federation