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.

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

Sponsors

Lead sponsor: European Lung Cancer Working Party

Source 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.

Overall Status Recruiting
Start Date January 2013
Completion Date December 2021
Primary Completion Date December 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Capability of diagnosing lung nodule with ENB (Sensitivity) After the procedure
Secondary Outcome
Measure Time Frame
Prediction of malignancy After the procedure
Enrollment 120
Condition
Intervention

Intervention type: Procedure

Intervention name: Bronchoscopy

Description: 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.

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Thierry Berghmans, MD, PhD Thierry Berghmans, MD, PhD Thierry Berghmans, MD, PhD
003225413191 003225413191 003225413191
Overall Contact

Last name: Thierry Berghmans, MD, PhD

Phone: 003225413191

Location
facility status contact investigator
Institut Jules Bordet Recruiting Nathalie Leclercq, RN 003225413192 [email protected] Thierry Berghmans, MD, PhD Principal Investigator
Location Countries

Belgium

Verification Date

February 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Bronchoscopy guided by fluoroscopy

Arm group type: Other

Description: Bronchoscopy guided by fluoroscopy followed by ENG

Arm group label: Bronchoscopy guided by electromagnetic navigation

Arm group type: Experimental

Description: Bronchoscopy guided by ENG followed by fluoroscopy

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov