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

NCT ID: NCT01779388

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2021-12-31

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.

Conditions

Pulmonary Nodule Cm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Bronchoscopy guided by fluoroscopy

Bronchoscopy guided by fluoroscopy followed by ENG

Group Type: OTHER

Bronchoscopy

Intervention Type: PROCEDURE

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.

Bronchoscopy guided by electromagnetic navigation

Bronchoscopy guided by ENG followed by fluoroscopy

Group Type: EXPERIMENTAL

Bronchoscopy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Lung Cancer Working Party

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry Berghmans, MD, PhD

Role: STUDY_CHAIR

ELCWP

Dimitri Leduc, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ELCWP

Locations

Institut Jules Bordet

Brussels, , Belgium

Countries

Belgium

Other Identifiers

01201

Identifier Type: -

Identifier Source: org_study_id