Evaluating the Pulmonary Nodule With Imaging and Biomarkers

Not Applicable

• Conditions: Lung Cancer

• Registration Number: NCT01739881
• Lead Sponsor: National University Hospital, Singapore

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

1. To improve diagnostic yield of pulmonary nodule or mass by using combined approach of navigation bronchoscopy and EBUS.

2. 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.

3. 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.

Study Timeline

• Study Start: 2011-04
• Status Verified: 2012-07
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-11-28
• Last Update Submitted: 2012-11-28
• Study First Posted: 2012-12-04
• Last Update Posted: 2012-12-04
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlating pathology between EBUS, confocal microendoscopy and VOC patterns to aid in characterising malignant and benign etiology.

Trial Locations

Locations (1)

National University Hospital/ National University of Singapore; 🇸🇬 Singapore, Singapore