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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00377338
First received: September 15, 2006
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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 Phase
Respiratory Tract Diseases
Phase 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase II Study of Broncho-Alveoscopy Using Fibered Confocal Fluorescence Microscopy

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • number of lesions localized by confocal endoscopy compared to navigational bronchoscopy [ Time Frame: time of the confocal endoscopy compared to navigational bronchoscopy ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

distal lung biopsy if of tumoral nature (fixed or frozen sample)


Enrollment: 270
Study Start Date: May 2006
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377338

Locations
France
Rouen University Hospital
Rouen, Haute Normandie, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Luc C Thiberville, MD Rouen University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00377338     History of Changes
Other Study ID Numbers: 2005/102/HP, ALVEOLE
Study First Received: September 15, 2006
Last Updated: July 29, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Bronchoscopy
Diagnostic imaging
Laser scanning confocal microscopy
Pulmonary Alveoli
Healthy volunteers
Diffuse peripheral lung disease
Focal peripheral lung disease

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on April 17, 2014