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

Primary Purpose

Inflammatory, Interstitial, Rare Lung Diseases

Status

Unknown status

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

miniprobe Alveoflex

About this trial

This is an interventional diagnostic trial for Inflammatory, Interstitial, Rare Lung Diseases focused on measuring alveoflex, probe-based confocal laser endomicroscopy, pCLE, alveoscopy, morphology, high resolution computed tomography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

Federal Research Clinical Center FMBA RussiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alveoflex, in vivo imaging miniprobe

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Full Information

NCT ID

NCT02006940

First Posted

November 28, 2013

Last Updated

December 5, 2013

Sponsor

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

1. Study Identification

Unique Protocol Identification Number

NCT02006940

Brief Title

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

Acronym

pCLE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory, Interstitial, Rare Lung Diseases

Keywords

alveoflex, probe-based confocal laser endomicroscopy, pCLE, alveoscopy, morphology, high resolution computed tomography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alveoflex, in vivo imaging miniprobe

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

miniprobe Alveoflex

Other Intervention Name(s)

Cellvizio system (Mauna Kea Technologies, Paris, France)

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants with the Correspondence of pCLE Images to HRCT and Morphologic Data as a Measure of Specificity and Sensitivity of the Method

Description

Time Frame

up to three years

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time Frame

up to two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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,

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Olesya V. Danilevskaya, MD

Phone

+7(916)9819853

danless@mail.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olesya Danilevskaya, MD

Organizational Affiliation

Federal Research Clinical Center FMBA Russia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Federal Research Clinical Center FMBA Russia

City

Moscow

ZIP/Postal Code

115682

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olesya V. Danilevskaya, MD

Phone

+7(916)9819853

danless@mail.ru

First Name & Middle Initial & Last Name & Degree

Alexander V. Averyanov, MD, PhD

First Name & Middle Initial & Last Name & Degree

Anastasia V. Sorokina, MD

First Name & Middle Initial & Last Name & Degree

Dmitry V. Sazonov, MD

First Name & Middle Initial & Last Name & Degree

Viktor N. Zabozlaev, MD

First Name & Middle Initial & Last Name & Degree

Anna G. Sotnikova, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

25590481

Citation

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.

Results Reference

derived

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

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