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

NCT02006940 | Unknown

• 1 other identifier: FRCC FMBA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory, Interstitial, Rare Lung Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  up to two years

Study Arms (1)

Alveoflex, in vivo imaging miniprobe

EXPERIMENTAL

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

Interventions

miniprobe Alveoflex 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

Also known as: Cellvizio system (Mauna Kea Technologies, Paris, France)

Alveoflex, in vivo imaging miniprobe

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Federal Research Clinical Center of Federal Medical & Biological Agency, Russia: lead

Study Sites (1)

Federal Research Clinical Center FMBA Russia

Moscow, 115682, Russia

RECRUITING

Related Publications (1)

• 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.

  PMID: 25590481 DERIVED

Study Officials

• Olesya Danilevskaya, MD

  Federal Research Clinical Center FMBA Russia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olesya V. Danilevskaya, MD

CONTACT

+7(916)9819853; danless@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 10, 2013
• Study Start: September 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2016
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

RU (1)