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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Singapore General Hospital
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01624753
First received: May 15, 2012
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Diffuse Parenchymal Lung Diseases
Device: Fibered confocal fluorescence microscopy imaging (Alveoflex Confocal MiniprobeTM )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Utility of Fibered Confocal Fluorescence Microscopy Imaging in Patients With Diffuse Parenchymal Lung Diseases

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Univariate and multivariate logistic regression analysis of the FCFM image features identified to discriminate against HRCT features and pathology. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Using Kappa values to quantify a high study agreement (kappa >0.8) between the assessors and within an assessor for FCFM image interpretation. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Complication rate of fibered confocal fluorescence microscopy over and above standard bronchoscopy. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: May 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Fibered confocal fluorescence microscopy imaging (Alveoflex Confocal MiniprobeTM )
    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.
    Other Names:
    • confocal microscopy
    • alveoloscopy
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Contraindications to bronchoscopic evaluation eg. Haemodynamic instability, respiratory failure, uncorrected coagulopathy
  2. Suspected/confirmed pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624753

Contacts
Contact: Su Ying Low, BMBCh +65 63214700 low.su.ying@sgh.com.sg
Contact: Devanand Anantham, MBBS +65 63214700 anantham.devanand@sgh.com.sg

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Principal Investigator: Su Ying Low, BMBCh         
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Su Ying Low, BMBCh Singapore General Hospital
  More Information

Publications:
Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01624753     History of Changes
Other Study ID Numbers: 2012/245/Cfcfm
Study First Received: May 15, 2012
Last Updated: June 20, 2012
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Singapore General Hospital:
interstitial lung disease
interstitial pneumonia
idiopathic pulmonary fibrosis

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

ClinicalTrials.gov processed this record on July 20, 2014