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

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.

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

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

• France
  • Haute Normandie
    • Rouen, Haute Normandie, France, 76000
      • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of lesions localized by confocal endoscopy compared to navigational bronchoscopy	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.	before and after IV fluorophore injection for the diagnosis of cancer.

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Luc c Thiberville, MD, Rouen University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 15, 2006
• First Submitted That Met QC Criteria: September 15, 2006
• First Posted (Estimate): September 18, 2006

Study Record Updates

• Last Update Posted (Estimate): July 30, 2013
• Last Update Submitted That Met QC Criteria: July 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Healthy volunteers; Diagnostic imaging; Bronchoscopy; Pulmonary Alveoli; Laser scanning confocal microscopy; Diffuse peripheral lung disease; Focal peripheral lung disease
• Additional Relevant MeSH Terms: Lung Diseases; Respiratory Tract Diseases
• Other Study ID Numbers: 2005/102/HP; ALVEOLE