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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.
 
ClinicalTrials.gov Identifier: NCT00377338
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date September 15, 2006
First Posted Date September 18, 2006
Last Update Posted Date July 30, 2013
Study Start Date May 2006
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2013)
  • 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. ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Accuracy of Alveoscopy in Interstitial Lung Diseases
Official Title Phase II Study of Broncho-Alveoscopy Using Fibered Confocal Fluorescence Microscopy
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
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
distal lung biopsy if of tumoral nature (fixed or frozen sample)
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
Condition Respiratory Tract Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Salaün 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 29, 2013)
270
Original Enrollment
 (submitted: September 15, 2006)
100
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00377338
Other Study ID Numbers 2005/102/HP
ALVEOLE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor University Hospital, Rouen
Collaborators Not Provided
Investigators
Principal Investigator: Luc C Thiberville, MD Rouen University Hospital
PRS Account University Hospital, Rouen
Verification Date July 2013