Innovation in Endobronchial Sampling

Diffuse Interstitial Lung Disease Clinical Trial

Official title:

Innovation in Endobronchial Sampling : Integration of Virtual Bronchoscopic Navigation in the Current Diagnostic Algorithm and the Use of Micro-CT for Tissue Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02380326
• Other study ID #: 150302V02
• Status: Recruiting
• Start date: October 2015
• Est. completion date: December 2021

Study information

• Verified date: May 2018
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluating an integrated diagnostic work-up of virtual navigation bronchoscopy (VNB), confocal laser endomicroscopy and micro computerized tomography (micro-CT) in the diagnostic path of pulmonary lesions in the non-oncological patient.

Description:

The region(s) of interest that has/have to be sampled, will be selected upfront. Guided by the endobronchial pathway that is created by virtual bronchoscopy, the flexible bronchoscope will be navigated to the regions of interest and an optical biopsy of the region will be obtained using pCLE. One biopsy sample will be processed in the endoscopy suite to be able to prepare it for micro-CT analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Presence of diffuse pulmonary disease necessitating bronchoscopic evaluation.

• Informed consent available

• Age > 18

• FVC > 50%pred

• DLCO > 35%pred

• PaO2 > 55 mmHg, pCO2 < 45 mmHg (ambient air)

• No exclusion criteria

Exclusion Criteria:

• Age > 75

• Systolic arterial pressure in the pulmonary artery : PAPS >40mmHg

• Platelet count <100000/µl

• INR > 1.4

• BMI >30

• Diffuse bullous lung disease

• Active anti-platelet or anticoagulant treatment

• Active heart failure or unstable coronary heart disease

Related Conditions & MeSH terms

• Diffuse Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Procedure:
• Advanced endoscopic imaging modalities
Virtual bronchoscopic navigation, confocal laser endomicroscopy, micro CT

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield		postprocedural