Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01779388
Recruitment Status : Recruiting
First Posted : January 30, 2013
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
European Lung Cancer Working Party

Tracking Information
First Submitted Date  ICMJE January 28, 2013
First Posted Date  ICMJE January 30, 2013
Last Update Posted Date June 26, 2020
Actual Study Start Date  ICMJE January 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
Capability of diagnosing lung nodule with ENB (Sensitivity) [ Time Frame: After the procedure ]
Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
Prediction of malignancy [ Time Frame: After the procedure ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pulmonary Nodule Cm
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Bronchoscopy guided by fluoroscopy
    Bronchoscopy guided by fluoroscopy followed by ENG
    Intervention: Procedure: Bronchoscopy
  • Experimental: Bronchoscopy guided by electromagnetic navigation
    Bronchoscopy guided by ENG followed by fluoroscopy
    Intervention: Procedure: Bronchoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2013)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thierry Berghmans, MD, PhD 003225413191
Contact: Nathalie Leclercq, RN 003225413192 nathalie.leclercq@bordet.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01779388
Other Study ID Numbers  ICMJE 01201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party European Lung Cancer Working Party
Study Sponsor  ICMJE European Lung Cancer Working Party
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Thierry Berghmans, MD, PhD ELCWP
Principal Investigator: Dimitri Leduc, MD, PhD ELCWP
PRS Account European Lung Cancer Working Party
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP