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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Utility of Fibered Confocal Fluorescence Microscopy Imaging in Patients With Diffuse Parenchymal Lung Diseases

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.


Detailed Summary:

Diffuse parenchymal lung diseases (DPLD) represent a large and heterogeneous group of disorders encompassing a collection of pulmonary diseases that affect the interstitium including the alveolar epithelium, pulmonary capillary endothelium, basement membrane, perivascular and perilymphatic tissues. This spectrum of disease is encountered not only in pulmonary medicine as a collection of idiopathic conditions, but also in transplant medicine (solid organ and haematological), infectious disease (atypical pneumonias) and rheumatology (connective tissue disease/vasculitis). Although new techniques such as high resolution computed tomography (HRCT) and insights into the pathogenesis have led to a better understanding of DPLD, clinical diagnosis, management and prognostication remains a challenge.

The current diagnostic standard of DPLD is a correlation between clinical course, radiological features on HRCT and pathological findings. Even in idiopathic pulmonary fibrosis (IPF) where a typical usual interstitial pattern on HRCT is pathognomonic without the requirement of pathology, this is only diagnostic in 80% of patients, and an atypical pattern on HRCT does not preclude a diagnosis of IPF. As such the final diagnosis often hinges on histopathological confirmation which traditionally requires a surgical lung biopsy under general anaesthetic via thoracoscopy or thoracotomy. This entails significant morbidity and mortality in this group of patients who already have respiratory compromise. Minimally invasive endoscopic procedures such as bronchoalveolar lavage (BAL) and transbronchial lung biopsy (TBLB) via flexible bronchoscopy have increasingly been used in the majority of cases as a substitute to surgical biopsy. This unfortunately is not entirely a benign procedure either - BAL can worsen hypoxaemia, and TBLB may lead to significant bleeding or pneumothorax in around 5% of p
Sponsor: Singapore General Hospital

Current Primary Outcome: Univariate and multivariate logistic regression analysis of the FCFM image features identified to discriminate against HRCT features and pathology. [ Time Frame: 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]
  • Complication rate of fibered confocal fluorescence microscopy over and above standard bronchoscopy. [ Time Frame: 5 years ]


Original Secondary Outcome: Same as current

Information By: Singapore General Hospital

Dates:
Date Received: May 15, 2012
Date Started: May 2012
Date Completion: April 2017
Last Updated: October 27, 2016
Last Verified: October 2016