Evaluating the Pulmonary Nodule With Imaging and Biomarkers

NCT01739881 | Unknown

• 1 other identifier: DSRB/2011/00380
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Exhaled breath condensate (EBC) method; Volatile Organic Compounds (VOCs); Endobronchial Ultrasound (EBUS); Confocal Endoscopy; Exhaled alveolar gas

Outcome Measures

Primary Outcomes (1)

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

Interventions

Olympus Ultrathin Bronchofibervideoscope (XP260F) DEVICE

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.

Also known as: Olympus Lucera Broncho Fibervideoscope (BF-XP260F)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital/ National University of Singapore

Singapore, Singapore, 119228, Singapore

RECRUITING

Related Publications (12)

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  PMID: 20610543 BACKGROUND

• Lee P, Colt HG. Bronchoscopy in lung cancer: appraisal of current technology and for the future. J Thorac Oncol. 2010 Aug;5(8):1290-300. doi: 10.1097/JTO.0b013e3181e41843.

  PMID: 20661089 BACKGROUND

• Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003 Jan;123(1 Suppl):115S-128S. doi: 10.1378/chest.123.1_suppl.115s.

  PMID: 12527571 BACKGROUND

• Kurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65. doi: 10.1378/chest.126.3.959.

  PMID: 15364779 BACKGROUND

• Herth FJ, Ernst A, Becker HD. Endobronchial ultrasound-guided transbronchial lung biopsy in solitary pulmonary nodules and peripheral lesions. Eur Respir J. 2002 Oct;20(4):972-4. doi: 10.1183/09031936.02.00032001.

  PMID: 12412691 BACKGROUND

• Herth FJ, Eberhardt R, Becker HD, Ernst A. Endobronchial ultrasound-guided transbronchial lung biopsy in fluoroscopically invisible solitary pulmonary nodules: a prospective trial. Chest. 2006 Jan;129(1):147-50. doi: 10.1378/chest.129.1.147.

  PMID: 16424425 BACKGROUND

• Eberhardt R, Kahn N, Gompelmann D, Schumann M, Heussel CP, Herth FJ. LungPoint--a new approach to peripheral lesions. J Thorac Oncol. 2010 Oct;5(10):1559-63. doi: 10.1097/JTO.0b013e3181e8b308.

  PMID: 20802352 BACKGROUND

• Goerres GW, Kamel E, Heidelberg TN, Schwitter MR, Burger C, von Schulthess GK. PET-CT image co-registration in the thorax: influence of respiration. Eur J Nucl Med Mol Imaging. 2002 Mar;29(3):351-60. doi: 10.1007/s00259-001-0710-4.

  PMID: 12002710 BACKGROUND

• Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. doi: 10.1164/rccm.200603-344OC. Epub 2006 Jul 27.

  PMID: 16873767 BACKGROUND

• Makris D, Scherpereel A, Leroy S, Bouchindhomme B, Faivre JB, Remy J, Ramon P, Marquette CH. Electromagnetic navigation diagnostic bronchoscopy for small peripheral lung lesions. Eur Respir J. 2007 Jun;29(6):1187-92. doi: 10.1183/09031936.00165306. Epub 2007 Mar 14.

  PMID: 17360724 BACKGROUND

• Eberhardt R, Anantham D, Ernst A, Feller-Kopman D, Herth F. Multimodality bronchoscopic diagnosis of peripheral lung lesions: a randomized controlled trial. Am J Respir Crit Care Med. 2007 Jul 1;176(1):36-41. doi: 10.1164/rccm.200612-1866OC. Epub 2007 Mar 22.

  PMID: 17379850 BACKGROUND

• Horvath I, Lazar Z, Gyulai N, Kollai M, Losonczy G. Exhaled biomarkers in lung cancer. Eur Respir J. 2009 Jul;34(1):261-75. doi: 10.1183/09031936.00142508.

  PMID: 19567608 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pyng Lee, MD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pyng Lee, MD

CONTACT

+65-67795555; mdclp@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: December 4, 2012
• Study Start: April 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 4, 2012

Record last verified: 2012-07

Locations

SG (1)