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Safety and Accuracy of Alveoscopy in Interstitial Lung Diseases (ALVEOLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00377338
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
University Hospital, Rouen

Brief 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. 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

Condition or disease
Respiratory Tract 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.

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Study Type : Observational
Actual Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase II Study of Broncho-Alveoscopy Using Fibered Confocal Fluorescence Microscopy
Study Start Date : May 2006
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Primary Outcome Measures :
  1. number of lesions localized by confocal endoscopy compared to navigational bronchoscopy [ Time Frame: time of the confocal endoscopy compared to navigational bronchoscopy ]
  2. 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. ]

Biospecimen Retention:   Samples Without DNA
distal lung biopsy if of tumoral nature (fixed or frozen sample)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Bleeding disorders
  • Pulmonary hypertension
  • Contraindication for a bronchoscopy
  • known hypersensitivity to the fluorescent contrast agent (if required)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00377338

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Rouen University Hospital
Rouen, Haute Normandie, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
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Principal Investigator: Luc C Thiberville, MD Rouen University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Rouen Identifier: NCT00377338    
Other Study ID Numbers: 2005/102/HP
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013
Keywords provided by University Hospital, Rouen:
Diagnostic imaging
Laser scanning confocal microscopy
Pulmonary Alveoli
Healthy volunteers
Diffuse peripheral lung disease
Focal peripheral lung disease
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases