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Evaluating the Pulmonary Nodule With Imaging and Biomarkers

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ClinicalTrials.gov Identifier: NCT01739881
Recruitment Status : Unknown
Verified July 2012 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Lung Cancer Device: Olympus Ultrathin Bronchofibervideoscope (XP260F)

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluating the Pulmonary Nodule With Imaging and Biomarkers
Study Start Date : April 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.
    Other Name: Olympus Lucera Broncho Fibervideoscope (BF-XP260F)

Outcome Measures

Primary Outcome Measures :
  1. Correlating pathology between EBUS, confocal microendoscopy and VOC patterns to aid in characterising malignant and benign etiology.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739881


Contacts
Contact: Pyng Lee, MD +65-67795555 mdclp@nus.edu.sg

Locations
Singapore
National University Hospital/ National University of Singapore Recruiting
Singapore, Singapore, 119228
Contact: Pyng Lee, MD    +65-67795555    mdclp@nus.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Pyng Lee, MD National University Hospital, Singapore
More Information

Publications:

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01739881     History of Changes
Other Study ID Numbers: DSRB/2011/00380
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: July 2012

Keywords provided by National University Hospital, Singapore:
Exhaled breath condensate (EBC) method
Volatile Organic Compounds (VOCs)
Endobronchial Ultrasound (EBUS)
Confocal Endoscopy
Exhaled alveolar gas

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases