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

Comparative Study Of The Methods Of Probe-Based Confocal Laser Endomicroscopy Of Distal Airways, High Resolution Computed Tomography And Morphology In Diagnostics Of Lung Diseases

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory, Interstitial, Rare Lung Diseases
• Intervention / Treatment: Device: miniprobe Alveoflex

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115682
    • Recruiting
    • Federal Research Clinical Center FMBA Russia
    • Sub-Investigator: Alexander V. Averyanov, MD, PhD
    • Sub-Investigator: Anastasia V. Sorokina, MD
    • Sub-Investigator: Dmitry V. Sazonov, MD
    • Sub-Investigator: Viktor N. Zabozlaev, MD
    • Sub-Investigator: Anna G. Sotnikova, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alveoflex, in vivo imaging miniprobe; 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.	Device: miniprobe Alveoflex; Alveoflex uses 488nm laser, generating real time moving images with an optical area of 600μm at a video frame rate of 12 images per second and a focus depth of 50μm; Other Names: Cellvizio system (Mauna Kea Technologies, Paris, France)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with the Correspondence of pCLE Images to HRCT and Morphologic Data as a Measure of Specificity and Sensitivity of the Method	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.	up to three years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Investigators: Principal Investigator: Olesya Danilevskaya, MD, Federal Research Clinical Center FMBA Russia

Publications and helpful links

General Publications

• Danilevskaya O, Averyanov A, Lesnyak V, Chernyaev A, Sorokina A. Confocal laser endomicroscopy for diagnosis and monitoring of pulmonary alveolar proteinosis. J Bronchology Interv Pulmonol. 2015 Jan;22(1):33-40. doi: 10.1097/LBR.0000000000000126.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: November 28, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 10, 2013

Study Record Updates

• Last Update Posted (Estimate): December 10, 2013
• Last Update Submitted That Met QC Criteria: December 5, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: pCLE; probe-based confocal laser endomicroscopy; morphology; alveoflex; alveoscopy; high resolution computed tomography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: FRCC FMBA