Fibered Confocal Fluorescence Microscopy Imaging in Patients With Diffuse Parenchymal Lung Diseases

NCT01624753 | Completed

• 1 other identifier: 2012/245/Cfcfm
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Fibered confocal fluorescence microscopy (FCFM) (CellvizioR Lung, MaunaKea Technologies, France) could potentially provide diagnostic information on fibrosis and inflammation of the distal air spaces associated with diffuse parenchymal lung diseases without the need for lung biopsies, thereby fulfilling the gap in the investigators current medical practice of a minimally invasive procedures with few complications and a high diagnostic fidelity. In patients scheduled for bronchoscopy as part of regular clinical care/diagnostic workup, the investigators will offer the patient concurrent FCFM imaging to be performed during the bronchoscopic procedure. The investigators aim to identify and catalogue distinct and discriminating features seen on images obtained from fibered confocal fluorescence microscopy in this group of patients, and to correlate these findings with specific high resolution computed tomography (HRCT) features and pathological findings if available. Eventually the investigators hope to create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of specific diffuse parenchymal lung disease entities.

Conditions

Diffuse Parenchymal Lung Diseases

Keywords

interstitial lung disease; interstitial pneumonia; idiopathic pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

• Univariate and multivariate logistic regression analysis of the FCFM image features identified to discriminate against HRCT features and pathology.

  5 years

Secondary Outcomes (4)

• Utilize receiver operating characteristic (ROC) curves to identify the FCFM image feature or combination of features which demonstrates the best sensitivity and specificity for each HRCT feature and pathology.

  5 years

• Comparison of the areas under the curves for the interpretation of 2 still FCFM image frames of the same sequence recording of a single alveolar segment.

  5 years

• Using Kappa values to quantify a high study agreement (kappa >0.8) between the assessors and within an assessor for FCFM image interpretation.

  5 years

• Complication rate of fibered confocal fluorescence microscopy over and above standard bronchoscopy.

  5 years

Study Arms (1)

confocal microscopy

EXPERIMENTAL

During bronchoscopy, one side of the bronchial tree will be examined (either right or left) and targeted based on pre-procedure HRCT/CT scan findings. A 1.4mm diameter Alveoflex Confocal MiniprobeTM (MaunaKea Technologies, France) will be deployed down the working channel of the standard bronchoscope and advanced distally into the alveoli. Images are acquired by gentle contact providing real-time imaging and microstructural detail of the alveolus which will be continuously recorded during the procedure and stored for further morphometric and cellular analyses. Up to 10 bronchoalveolar areas will be observed and the location of the corresponding lung segment will be registered according to the international bronchial nomenclature.

Device: confocal microscopy

Interventions

confocal microscopy DEVICE

During bronchoscopy, one side of the bronchial tree will be examined (either right or left) and targeted based on pre-procedure HRCT/CT scan findings. A 1.4mm diameter Alveoflex Confocal MiniprobeTM (MaunaKea Technologies, France) will be deployed down the working channel of the standard bronchoscope and advanced distally into the alveoli. Images are acquired by gentle contact providing real-time imaging and microstructural detail of the alveolus which will be continuously recorded during the procedure and stored for further morphometric and cellular analyses. Up to 10 bronchoalveolar areas will be observed and the location of the corresponding lung segment will be registered according to the international bronchial nomenclature.

Also known as: Fibered confocal fluorescence microscopy imaging, alveoloscopy, Alveoflex Confocal MiniprobeTM

confocal microscopy

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 21 years old and older diagnosed with suspected diffuse parenchymal lung disease (multi-lobar pulmonary infiltrates)
• Patients scheduled for bronchoscopy as part of regular clinical care/diagnostic workup
• Ability and willingness to sign informed consent

You may not qualify if:

• Contraindications to bronchoscopic evaluation eg. Haemodynamic instability, respiratory failure, uncorrected coagulopathy
• Suspected/confirmed pregnancy

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (4)

• American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.

  PMID: 11790668 BACKGROUND

• Thiberville L, Salaun M, Lachkar S, Dominique S, Moreno-Swirc S, Vever-Bizet C, Bourg-Heckly G. Human in vivo fluorescence microimaging of the alveolar ducts and sacs during bronchoscopy. Eur Respir J. 2009 May;33(5):974-85. doi: 10.1183/09031936.00083708. Epub 2009 Feb 12.

  PMID: 19213792 BACKGROUND

• Thiberville L, Moreno-Swirc S, Vercauteren T, Peltier E, Cave C, Bourg Heckly G. In vivo imaging of the bronchial wall microstructure using fibered confocal fluorescence microscopy. Am J Respir Crit Care Med. 2007 Jan 1;175(1):22-31. doi: 10.1164/rccm.200605-684OC. Epub 2006 Oct 5.

  PMID: 17023733 BACKGROUND

• Newton RC, Kemp SV, Yang GZ, Elson DS, Darzi A, Shah PL. Imaging parenchymal lung diseases with confocal endomicroscopy. Respir Med. 2012 Jan;106(1):127-37. doi: 10.1016/j.rmed.2011.09.009. Epub 2011 Oct 14.

  PMID: 22000588 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis

Interventions

Microscopy, Confocal

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Su Ying Low, BMBCh

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: June 21, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

SG (1)