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Evaluating the Pulmonary Nodule With Imaging and Biomarkers

NCT ID: NCT01739881

Last Updated: 2012-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Olympus Lucera Broncho Fibervideoscope (BF-XP260F)

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pyng Lee, MD

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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National University Hospital/ National University of Singapore

Singapore, Singapore, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Pyng Lee, MD

Role: CONTACT

Phone: +65-67795555

Email: [email protected]

Facility Contacts

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Pyng Lee, MD

Role: primary

References

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Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7.

Reference Type BACKGROUND
PMID: 20610543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20661089 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12527571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15364779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12412691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16424425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20802352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12002710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16873767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17360724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17379850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19567608 (View on PubMed)

Other Identifiers

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DSRB/2011/00380

Identifier Type: -

Identifier Source: org_study_id