Evaluating the Pulmonary Nodule With Imaging and Biomarkers

Study Overview
=================
Brief Summary
-----------------
The study aims to determine if there are defining EBUS and confocal endoscopy features as well as exhaled alveolar gas VOC that can discriminate malignant pulmonary nodules or masses from benign etiology, thereby obviating unnecessary thoracotomy. Directly sampled alveolar gas VOC from patients with lung cancer will be compared against exhaled breath VOC for signature compounds that may complement CT in screening the population at risk.

Detailed Description
-----------------
AIMS To improve diagnostic yield of pulmonary nodule or mass by using combined approach of navigation bronchoscopy and EBUS. To determine if characteristic features of EBUS and confocal microendoscopy exist as well as VOC patterns in alveolar and exhaled gas that can aid in discriminating malignant pulmonary nodule or mass from benign etiology by correlating with pathology. To identify VOC patterns specific for lung cancer by correlating VOC from directly sampled alveolar gas and exhaled breath with pathology. Exhaled breath VOC signature may complement CT in screening population at risk.

Official Title
-----------------
Evaluating the Pulmonary Nodule With Imaging and Biomarkers

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: Olympus Ultrathin Bronchofibervideoscope (XP260F)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses. Exclusion Criteria: Patients with contra-indications to bronchoscopy and CT-TTNA that include active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. Before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Olympus Ultrathin Bronchofibervideoscope (XP260F)|The bronchovideoscope will be used together with an assisted image-guided bronchoscopic navigation software system called LungPoint®, to view lungs in a real time 3D manner.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlating pathology between EBUS, confocal microendoscopy and VOC patterns to aid in characterising malignant and benign etiology. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exhaled breath condensate (EBC) method, Volatile Organic Compounds (VOCs), Endobronchial Ultrasound (EBUS), Confocal Endoscopy, Exhaled alveolar gas