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

NCT ID: NCT02006940

Last Updated: 2013-12-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-09-30

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.

Conditions

Inflammatory, Interstitial, Rare Lung Diseases

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

miniprobe Alveoflex

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Cellvizio system (Mauna Kea Technologies, Paris, France)

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olesya Danilevskaya, MD

Role: PRINCIPAL_INVESTIGATOR

Federal Research Clinical Center FMBA Russia

Locations

Federal Research Clinical Center FMBA Russia

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Olesya V. Danilevskaya, MD

Role: CONTACT

Phone: +7(916)9819853

Email: danless@mail.ru

Facility Contacts

Olesya V. Danilevskaya, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 25590481 (View on PubMed)

Other Identifiers

FRCC FMBA

Identifier Type: -

Identifier Source: org_study_id