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

• ClinicalTrials.gov Identifier: NCT01779388
• Recruitment Status: Recruiting
• First Posted: January 30, 2013
• Last Update Posted: June 26, 2020
• Sponsor: European Lung Cancer Working Party
• Information provided by (Responsible Party): European Lung Cancer Working Party

Tracking Information

• First Submitted Date: January 28, 2013
• First Posted Date: January 30, 2013
• Last Update Posted Date: June 26, 2020
• Actual Study Start Date: January 2013
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules
• 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.
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Pulmonary Nodule Cm

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 29, 2013): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Thierry Berghmans, MD, PhD; 003225413191

Contact: Nathalie Leclercq, RN; 003225413192; nathalie.leclercq@bordet.be

• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT01779388
• Other Study ID Numbers: 01201
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: European Lung Cancer Working Party
• Study Sponsor: European Lung Cancer Working Party
• Collaborators: Not Provided

Investigators

• 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