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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Nodule Cm	Procedure: Bronchoscopy	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Actual Study Start Date: January 2013
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: European Lung Cancer Working Party
• ClinicalTrials.gov Identifier: NCT01779388
• Other Study ID Numbers: 01201
• First Posted: January 30, 2013
• Last Update Posted: June 26, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by European Lung Cancer Working Party:

Lung nodule; PET scanner; Bronchoscopy; Electromagnetic navigation

Additional relevant MeSH terms:

Multiple Pulmonary Nodules; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases