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

Primary Purpose

Pulmonary Nodule Cm

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
European Lung Cancer Working Party
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Nodule Cm focused on measuring Lung nodule, PET scanner, Bronchoscopy, Electromagnetic navigation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Jules Bordet

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Bronchoscopy guided by fluoroscopy

Bronchoscopy guided by electromagnetic navigation

Arm Description

Bronchoscopy guided by fluoroscopy followed by ENG

Bronchoscopy guided by ENG followed by fluoroscopy

Outcomes

Primary Outcome Measures

Capability of diagnosing lung nodule with ENB (Sensitivity)
Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule

Secondary Outcome Measures

Prediction of malignancy
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

Full Information

First Posted
January 28, 2013
Last Updated
March 22, 2022
Sponsor
European Lung Cancer Working Party
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1. Study Identification

Unique Protocol Identification Number
NCT01779388
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Lung Cancer Working Party

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Nodule Cm
Keywords
Lung nodule, PET scanner, Bronchoscopy, Electromagnetic navigation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bronchoscopy guided by fluoroscopy
Arm Type
Other
Arm Description
Bronchoscopy guided by fluoroscopy followed by ENG
Arm Title
Bronchoscopy guided by electromagnetic navigation
Arm Type
Experimental
Arm Description
Bronchoscopy guided by ENG followed by fluoroscopy
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Intervention 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.
Primary Outcome Measure Information:
Title
Capability of diagnosing lung nodule with ENB (Sensitivity)
Description
Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule
Time Frame
After the procedure
Secondary Outcome Measure Information:
Title
Prediction of malignancy
Description
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
Time Frame
After the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Berghmans, MD, PhD
Organizational Affiliation
ELCWP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dimitri Leduc, MD, PhD
Organizational Affiliation
ELCWP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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