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

NCT01779388 | Completed

• 1 other identifier: 01201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Lung nodule; PET scanner; Bronchoscopy; Electromagnetic navigation

Outcome Measures

Primary Outcomes (1)

• Capability of diagnosing lung nodule with ENB (Sensitivity)

  Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule

  After the procedure

Secondary Outcomes (1)

• Prediction of malignancy

  After the procedure

Study Arms (2)

Bronchoscopy guided by fluoroscopy

OTHER

Bronchoscopy guided by fluoroscopy followed by ENG

Procedure: Bronchoscopy

Bronchoscopy guided by electromagnetic navigation

EXPERIMENTAL

Bronchoscopy guided by ENG followed by fluoroscopy

Procedure: Bronchoscopy

Interventions

Bronchoscopy 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 fluoroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Lung Cancer Working Party: lead

Study Sites (1)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Thierry Berghmans, MD, PhD

  ELCWP

  STUDY CHAIR

• Dimitri Leduc, MD, PhD

  ELCWP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 4, 2022

Record last verified: 2021-08

Locations

BE (1)