Diffuse Interstitial Lung DiseaseNCT02380326
Innovation in Endobronchial Sampling
An observational study of Diffuse Interstitial Lung Disease, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Interstitial Lung Disease
- What is being tested?
- Advanced endoscopic imaging modalities
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung transplant recipients and diffuse interstitial lung disease without certain diagnosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Jonas Yserbyt, MD, +3216332211, jonas.yserbyt@uzleuven.be
About this study
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
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.
Read the detailed 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.
- Conditions
- Diffuse Interstitial Lung Disease
- Being tested
- Advanced endoscopic imaging modalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced endoscopic imaging modalitiesProcedure or surgery
Virtual bronchoscopic navigation, confocal laser endomicroscopy, micro CT
| Study group | Role | What they receive |
|---|---|---|
| Lung transplant recipients | Lung transplant recipients with diffuse parenchymal abnormalities subjected to advanced endoscopic imaging modalities Receives: Procedure: Advanced endoscopic imaging modalities | |
| Diffuse intersitial lung disease | Patients suffering from diffuse intersitial lung disease without a certain diagnosis subjected to advanced endoscopic imaging modalities Receives: Procedure: Advanced endoscopic imaging modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Measured: postprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yserbyt Jonas, KU Leuven
- Investigators
- Jonas Yserbyt, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380326
- Sponsor's protocol ID
- 150302V02
- Status last verified
- May 2018
- First submitted
- 2 Mar 2015
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02380326
- Acronym / sponsor ID
- 150302V02
- Conditions
- Diffuse Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung transplant recipients | – | Procedure: Advanced endoscopic imaging modalitiesLung transplant recipients with diffuse parenchymal abnormalities subjected to advanced endoscopic imaging modalities |
| Diffuse intersitial lung disease | – | Procedure: Advanced endoscopic imaging modalitiesPatients suffering from diffuse intersitial lung disease without a certain diagnosis subjected to advanced endoscopic imaging modalities |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung transplant recipients and diffuse interstitial lung disease without certain diagnosis
Key inclusion criteria (7 listed)
- Presence of diffuse pulmonary disease necessitating bronchoscopic evaluation.
- Informed consent available
- Age > 18
- FVC > 50%pred
- DLCO > 35%pred
Key exclusion criteria (8 listed)
- Age > 75
- Systolic arterial pressure in the pulmonary artery : PAPS >40mmHg
- Platelet count <100000/µl
- INR > 1.4
- BMI >30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced endoscopic imaging modalitiesVirtual bronchoscopic navigation, confocal laser endomicroscopy, micro CT | Procedure or surgery | Diffuse intersitial lung disease, Lung transplant recipients |
Primary outcome
Diagnostic yield
Time frame: postprocedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Yserbyt, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Interstitial Lung Disease, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: postprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.