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OpenTrials
Completed

NCT Number: NCT00377338

Safety and Accuracy of Alveoscopy in Interstitial Lung Diseases

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rouen University Hospital

Rouen, Haute Normandie, 76000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Phase II Study of Broncho-Alveoscopy Using Fibered Confocal Fluorescence Microscopy

Acronym: ALVEOLE

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Sep 18, 2006
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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