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Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by European Lung Cancer Working Party
Sponsor:
Information provided by (Responsible Party):
European Lung Cancer Working Party
ClinicalTrials.gov Identifier:
NCT01779388
First received: January 28, 2013
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

Due to CT screening, a lot of peripheral nodule not accessible to conventional endoscopy will be found. Electromagnetic navigation directed bronchoscopy (ENB) is a new technique needing validation. the primary aim of the study is to compare ENB to radiologically guided bronchoscopy, considered the standard comparator.


Condition Intervention Phase
Pulmonary Nodule Cm
Procedure: Bronchoscopy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Role of Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules of Indeterminate Nature. A Prospective Study by the European Lung Cancer Working Party.

Resource links provided by NLM:


Further study details as provided by European Lung Cancer Working Party:

Primary Outcome Measures:
  • Capability of diagnosing lung nodule with ENB (Sensitivity) [ Time Frame: After the procedure ] [ Designated as safety issue: Yes ]
    Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule


Secondary Outcome Measures:
  • Prediction of malignancy [ Time Frame: After the procedure ] [ Designated as safety issue: No ]
    To identify a predictive molecular signature able to predict the malignant nature of the nodule by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques in biopsies, alveolar lavage, blood and exhaled breath


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bronchoscopy guided by fluoroscopy
Bronchoscopy guided by fluoroscopy followed by ENG
Procedure: Bronchoscopy
During a general anaesthesia, an evaluation will be done by conventional bronchoscopy guided by fluoroscopy and by bronchial endoscopy guided by electromagnetic navigation, the selection of order in techniques being randomly assigned.
Experimental: Bronchoscopy guided by electromagnetic navigation
Bronchoscopy guided by ENG followed by fluoroscopy
Procedure: Bronchoscopy
During a general anaesthesia, an evaluation will be done by conventional bronchoscopy guided by fluoroscopy and by bronchial endoscopy guided by electromagnetic navigation, the selection of order in techniques being randomly assigned.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence on a conventional or low dose chest CT at least one lung nodule 5-20 mm in its largest axis, of indeterminate nature; the nodule must be positive at PET-CT examination (in case of PET-CT negative, only follow-up is proposed)
  • The pulmonary nodule(s) must be known for less than 6 months
  • The nodule appearance can be solid, presents as a ground glass opacity with solid component or as pure ground glass opacity
  • Availability for participating in the detailed follow-up of the protocol
  • Signed informed consent.
  • Age > 18 years

Exclusion Criteria:

  • Nodules found in the context of an active infection or for whom, the clinical context and/or additional available investigations (serology, microbiological samplings, immune abnormalities) show that cancer diagnosis is unlikely
  • Nodules found in the context of an active previously documented disease that can be associated with pulmonary nodules (anthracosilicosis, histoplasmosis, tuberculosis, autoimmune or rheumatoid diseases …)
  • Calcified nodule
  • Anticoagulation therapy of any type that cannot be suspended for the duration of the investigation
  • Respiratory failure, recent myocardial infarction (less than 3 months prior to the date of lung nodule screening), uncontrolled angina pectoris, congestive cardiac failure, cardiac arrhythmia, uncontrolled infectious disease or any other physical, biological or psychological factor which may prevent adherence to the study protocol or which may impair the patient's tolerance to the endoscopy and/or the general anaesthesia
  • Presence of a implanted cardiac device (pace-maker, defibrillator, …)
  • Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779388

Contacts
Contact: Thierry Berghmans, MD, PhD 003225413191
Contact: Nathalie Leclercq, RN 003225413192 nathalie.leclercq@bordet.be

Locations
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Nathalie Leclercq, RN    003225413192    nathalie.leclercq@bordet.be   
Principal Investigator: Thierry Berghmans, MD, PhD         
Sponsors and Collaborators
European Lung Cancer Working Party
Investigators
Study Chair: Thierry Berghmans, MD, PhD ELCWP
Principal Investigator: Dimitri Leduc, MD, PhD ELCWP
  More Information

Additional Information:
No publications provided

Responsible Party: European Lung Cancer Working Party
ClinicalTrials.gov Identifier: NCT01779388     History of Changes
Other Study ID Numbers: 01201
Study First Received: January 28, 2013
Last Updated: January 29, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by European Lung Cancer Working Party:
Lung nodule
PET scanner
Bronchoscopy
Electromagnetic navigation

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

ClinicalTrials.gov processed this record on November 27, 2014