Inflammatory, Interstitial, Rare Lung DiseasespCLENCT02006940
The Study Of Probe-Based Confocal Laser Endomicroscopy Of Distal Airways In Diagnostics Of Lung Diseases
A study testing miniprobe Alveoflex in people with Inflammatory, Interstitial, Rare Lung Diseases, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory, Interstitial, Rare Lung Diseases
- What is being tested?
- miniprobe Alveoflex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Federal Research Clinical Center FMBA Russia
Moscow, 115682
Olesya V. Danilevskaya, MD, +7(916)9819853, danless@mail.ru
Alexander V. Averyanov, MD, PhD
About this study
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
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.
Read the 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.
- Being tested
- miniprobe Alveoflex
- Keywords
- alveoflex, probe-based confocal laser endomicroscopy, pCLE, alveoscopy, morphology, high resolution computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miniprobe AlveoflexDevice
Also called Cellvizio system (Mauna Kea Technologies, Paris, France)
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: miniprobe Alveoflex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to three years
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startSep 2011
- Primary completionDec 2015 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory, Interstitial, Rare Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Olesya Danilevskaya, MD, Principal investigator, Federal Research Clinical Center FMBA Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006940
- Sponsor's protocol ID
- FRCC FMBA
- Acronym
- pCLE
- Status last verified
- Dec 2013
- First submitted
- 28 Nov 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25590481
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02006940
- Acronym / sponsor ID
- pCLE / FRCC FMBA
- Keywords
- alveoflex, probe-based confocal laser endomicroscopy, pCLE, alveoscopy, morphology, high resolution computed tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, RussiaOther government
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alveoflex, in vivo imaging miniprobe | Experimental | Device: miniprobe AlveoflexAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miniprobe AlveoflexAlso: Cellvizio system (Mauna Kea Technologies, Paris, France)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 | Device | Alveoflex, in vivo imaging miniprobe |
Primary outcome
Number of Participants with the Correspondence of pCLE Images to HRCT and Morphologic Data as a Measure of Specificity and Sensitivity of the Method
Time frame: up to three years
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.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
- Derived from this study: PubMed 25590481Danilevskaya 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olesya Danilevskaya, MD principal investigator
Federal Research Clinical Center FMBA Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miniprobe Alveoflex in people with Inflammatory, Interstitial, Rare Lung Diseases, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olesya V. Danilevskaya, MD (+7(916)9819853, danless@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: up to three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02006940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.