Respiratory Tract DiseasesALVEOLENCT00377338
Safety and Accuracy of Alveoscopy in Interstitial Lung Diseases
An observational study of Respiratory Tract Diseases, run by University Hospital, Rouen at 1 site in France.
Trial summary
Fibered confocal fluorescence microscopy (FCFM), also referred to as Cell-Vizio® (MaunaKea Technologies, France) is a new technique that produces microscopic imaging in a living tissue, through a 1 mm fiberoptic miniprobe that can be introduced into the working channel of the bronchoscope. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Diseases
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Jun 2013
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy smoker and non-smoker subjects, patients with no peripheral lung disease on CT scan, Patients with focal parenchymal lung diseases, patients with diffuse parenchymal lung diseases
Who may be able to join
- Healthy volunteers: normal chest X-rays and normal lung function tests
- Patients without parenchymal lung diseases: normal chest computed tomography (CT) scan, normal lung function tests, indication for a bronchoscopy
- Patients with parenchymal lung disease: indication for a bronchoscopy
- Written informed consent for the alveoscopy
Who cannot join
- Bleeding disorders
- Pulmonary hypertension
- Contraindication for a bronchoscopy
- known hypersensitivity to the fluorescent contrast agent (if required)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Broncho-Alveoscopy Using Fibered Confocal Fluorescence Microscopy
Fibered confocal fluorescence microscopy (FCFM), also referred to as Cell-Vizio® (MaunaKea Technologies, France) is a new technique that produces microscopic imaging in a living tissue, through a 1 mm fiberoptic miniprobe that can be introduced into the working channel of the bronchoscope. The system produces real-time imaging of endogenous fluorophores with a 5 µm lateral resolution and a field of view of 600 x 600 µm. FCFM is able to produce dynamic, high-resolution microimaging of the respiratory bronchiolar walls, alveolar ducts and sacs in vivo during endoscopy (a procedure termed as alveoscopy).
The hypothesis of this study is that an alveoscopy makes it possible to analyze the microstructure of the distal airways in vivo and to collect specific morphologic information in patients with interstitial lung diseases.
Read more
The goals of this French Phase II trial are:
- to evaluate the tolerance of the alveoscopy
- to describe the normal appearance of the bronchoalveolar system in spontaneous ventilation in normal subjects
- to describe specific alterations of the bronchoalveolar microstructure in focal or diffuse interstitial lung diseases
Read the detailed description
The study will include 40 healthy smoker or non-smoker volunteers, 20 patients with normal Chest CT scan and normal respiratory function tests, and 90 patients with focal or diffuse peripheral lung diseases.
The Alveoscopy will be performed under local anesthesia, in awake patients during a standard bronchoscopy. The Alveoscopy will be performed on one side of the bronchial tree (left or right lung). Two to ten separate bronchial areas will be explored in each patient, depending on the pathology, focal or diffuse, and the underlying respiratory function.
A continuous monitoring of the Oxygen saturation, blood pressure, EKG will be performed during the procedure. A chest X-ray will be performed after the procedure to eliminate a pneumothorax.
The morphometric parameters of the alveolar microstructure and their variability will be studied according to the age, gender, lung area explored, smoking status in healthy volunteers and "normal CT scan" subjects, as well as in patients with peripheral lung diseases.
- Conditions
- Respiratory Tract Diseases
- Keywords
- Bronchoscopy, Diagnostic imaging, Laser scanning confocal microscopy, Pulmonary Alveoli, Healthy volunteers, Diffuse peripheral lung disease, Focal peripheral lung disease
- Medical subject headings
- Respiratory Tract Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
number of lesions localized by confocal endoscopy compared to navigational bronchoscopy
Measured: time of the confocal endoscopy compared to navigational bronchoscopy
Positive and negative predictive values of confocal signs before and after IV fluorophore injection for the diagnosis of cancer.
Measured: before and after IV fluorophore injection for the diagnosis of cancer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2013
- Study completionJun 2013
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 Respiratory Tract DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc C Thiberville, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377338
- Sponsor's protocol ID
- 2005/102/HP
- Other IDs
- ALVEOLE
- Acronym
- ALVEOLE
- Status last verified
- Jul 2013
- First submitted
- 15 Sep 2006
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salaun M, Guisier F, Dominique S, Genevois A, Jounieaux V, Bergot E, Thill C, Piton N, Thiberville L. In vivo probe-based confocal laser endomicroscopy in chronic interstitial lung diseases: Specific descriptors and correlation with chest CT. Respirology. 2019 Aug;24(8):783-791. doi: 10.1111/resp.13507. Epub 2019 Feb 27.
PubMed 30811085
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Broncho-Alveoscopy Using Fibered Confocal Fluorescence Microscopy
- ClinicalTrials.gov ID
- NCT00377338
- Acronym / sponsor ID
- ALVEOLE / 2005/102/HP
- Conditions
- Respiratory Tract Diseases
- Keywords
- Bronchoscopy, Diagnostic imaging, Laser scanning confocal microscopy, Pulmonary Alveoli, Healthy volunteers, Diffuse peripheral lung disease, Focal peripheral lung disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Sep 2006 (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.
Fibered confocal fluorescence microscopy (FCFM), also referred to as Cell-Vizio® (MaunaKea Technologies, France) is a new technique that produces microscopic imaging in a living tissue, through a 1 mm fiberoptic miniprobe that can be introduced into the working channel of the bronchoscope. The system produces real-time imaging of endogenous fluorophores with a 5 µm lateral resolution and a field of view of 600 x 600 µm. FCFM is able to produce dynamic, high-resolution microimaging of the respiratory bronchiolar walls, alveolar ducts and sacs in vivo during endoscopy (a procedure termed as alveoscopy).
The hypothesis of this study is that an alveoscopy makes it possible to analyze the microstructure of the distal airways in vivo and to collect specific morphologic information in patients with interstitial lung diseases.
The goals of this French Phase II trial are:
- to evaluate the tolerance of the alveoscopy
- to describe the normal appearance of the bronchoalveolar system in spontaneous ventilation in normal subjects
- to describe specific alterations of the bronchoalveolar microstructure in focal or diffuse interstitial lung diseases
Detailed description
The study will include 40 healthy smoker or non-smoker volunteers, 20 patients with normal Chest CT scan and normal respiratory function tests, and 90 patients with focal or diffuse peripheral lung diseases.
The Alveoscopy will be performed under local anesthesia, in awake patients during a standard bronchoscopy. The Alveoscopy will be performed on one side of the bronchial tree (left or right lung). Two to ten separate bronchial areas will be explored in each patient, depending on the pathology, focal or diffuse, and the underlying respiratory function.
A continuous monitoring of the Oxygen saturation, blood pressure, EKG will be performed during the procedure. A chest X-ray will be performed after the procedure to eliminate a pneumothorax.
The morphometric parameters of the alveolar microstructure and their variability will be studied according to the age, gender, lung area explored, smoking status in healthy volunteers and "normal CT scan" subjects, as well as in patients with peripheral lung diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy smoker and non-smoker subjects, patients with no peripheral lung disease on CT scan, Patients with focal parenchymal lung diseases, patients with diffuse parenchymal lung diseases
Key inclusion criteria (4 listed)
- Healthy volunteers: normal chest X-rays and normal lung function tests
- Patients without parenchymal lung diseases: normal chest computed tomography (CT) scan, normal lung function tests, indication for a bronchoscopy
- Patients with parenchymal lung disease: indication for a bronchoscopy
- Written informed consent for the alveoscopy
Key exclusion criteria (4 listed)
- Bleeding disorders
- Pulmonary hypertension
- Contraindication for a bronchoscopy
- known hypersensitivity to the fluorescent contrast agent (if required)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of lesions localized by confocal endoscopy compared to navigational bronchoscopy
Time frame: time of the confocal endoscopy compared to navigational bronchoscopy
Positive and negative predictive values of confocal signs before and after IV fluorophore injection for the diagnosis of cancer.
Time frame: before and after IV fluorophore injection for the diagnosis of cancer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Derived from this study: PubMed 30811085Salaun M, Guisier F, Dominique S, Genevois A, Jounieaux V, Bergot E, Thill C, Piton N, Thiberville L. In vivo probe-based confocal laser endomicroscopy in chronic interstitial lung diseases: Specific descriptors and correlation with chest CT. Respirology. 2019 Aug;24(8):783-791. doi: 10.1111/resp.13507. Epub 2019 Feb 27.
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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.
Luc C Thiberville, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Diseases, run by University Hospital, Rouen at 1 site in France.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jul 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of lesions localized by confocal endoscopy compared to navigational bronchoscopy (time frame: time of the confocal endoscopy compared to navigational bronchoscopy). The study lists 2 primary outcomes in all. 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 NCT00377338, 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 30 Jul 2013.