Safety and Accuracy of Alveoscopy in Interstitial Lung Diseases

NCT00377338 | Completed DMC

• 2 other identifiers: 2005/102/HPALVEOLE
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Tract Diseases

Keywords

Bronchoscopy; Diagnostic imaging; Laser scanning confocal microscopy; Pulmonary Alveoli; Healthy volunteers; Diffuse peripheral lung disease; Focal peripheral lung disease

Outcome Measures

Primary Outcomes (2)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, Haute Normandie, 76000, France

Location

Related Publications (1)

• 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.

  PMID: 30811085 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Respiratory Tract Diseases

Study Officials

• Luc C Thiberville, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2006
• First Posted: September 18, 2006
• Study Start: May 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

FR (1)