Clinical trial NCT02006940: The Study Of Probe-Based Confocal Laser Endomicroscopy Of Distal Airways In Diagnostics Of Lung Diseases
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
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory, Interstitial, Rare Lung Diseases
Keywords: alveoflex
probe-based confocal laser endomicroscopy
pCLE
alveoscopy
morphology
high resolution computed tomography
Lead sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Sponsor class: OTHER_GOV
First posted: 2013-12-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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,

Primary outcomes:
measure: Number of Participants with the Correspondence of pCLE Images to HRCT and Morphologic Data as a Measure of Specificity and Sensitivity of the Method
timeFrame: up to three years
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to two years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Research Clinical Center FMBA Russia
Study officials:
affiliation: Federal Research Clinical Center FMBA Russia
name: Olesya Danilevskaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.