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Evaluating the Pulmonary Nodule With Imaging and Biomarkers


N/A
21 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Evaluating the Pulmonary Nodule With Imaging and Biomarkers


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Pyng Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore

Authority:

Singapore: Domain Specific Review Boards

Study ID:

DSRB/2011/00380

NCT ID:

NCT01739881

Start Date:

April 2011

Completion Date:

March 2013

Related Keywords:

  • Lung Cancer
  • Exhaled breath condensate (EBC) method
  • Volatile Organic Compounds (VOCs)
  • Endobronchial Ultrasound (EBUS)
  • Confocal Endoscopy
  • Exhaled alveolar gas
  • Lung Neoplasms

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