Interstitial Lung DiseasesNCT02689102
Confocal Laser Endomicroscopy and Optical Coherence Tomography for Diagnosing ILD.
An observational study of Interstitial Lung Diseases, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Often, assessing a classifying diagnosis in patients with interstitial lung disease provides a diagnostic challenge. Currently HRCT, endoscopic or surgical video assisted thoracoscopic surgery(VATS) assessment including lung biopsies are diagnostic tools for patients with suspected ILD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Diseases
- What is being tested?
- Probe based optical techniques
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Oct 2015to 22 Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of 18 years or older (n=20), who are suspected for ILD based on imaging (HRCT-scan) and with an indication for bronchoscopy with cryobiopsy.
Who may be able to join
- 18 years of age
- Supected ILD and referred for diagnostic bronchoscopic procedure with cryobiopsy
Who cannot join
- Smoked in the last 6 months
- Inability and willingness to provide informed consent
- Inability to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academisch Medisch Centrum
Amsterdam, North Holland, 1105 AZ
About this study
Official title: Confocal Laser Endomicroscopy and OCT for Diagnosing ILD, a Comparison With Imaging and Pathology.
Often, assessing a classifying diagnosis in patients with interstitial lung disease provides a diagnostic challenge. Currently HRCT, endoscopic or surgical video assisted thoracoscopic surgery(VATS) assessment including lung biopsies are diagnostic tools for patients with suspected ILD. However, tissue acquisition is associated with morbidity in these patients with an already compromised pulmonary function. In clinical practice this results in the fact that only a minor part of patients with an indication for tissue acquisition are actually undergoing biopsies. The aim of this study is to determine ILD-characteristics on imagign collected with minimal invasive novel optical techniques, to examine whether the addition of novel optical techniques to the diagnostic process of ILD could potentially limit the need for a tissue- (surgical) diagnosis and/or reduce the sampling error rate of biopsies by providing additional information on biopsy location.
Read the detailed description
Novel probe based optical techniques such as Confocal laser endomicroscopy (pCLE) and Optical coherence tomography (pOCT) are non-invasive optical techniques, compatible with conventional diagnostic bronchoscopes and provide non-invasive, real-time information on the airway wall and the alveolar compartment. Therefore, immediate validation of optical measurements during a biopsy is possible. Optical techniques might either obviate the need for an tissue biopsy or improve the diagnostic yield of conventional biopsy methods and make surgical lung biopsies that are associated with high morbidity and costs redundant.
Hypothesis: Novel optical techniques (pCLE and pOCT) provide real time information about the characteristics of the mucosa and/or the alveolar compartment in ILD.
- Conditions
- Interstitial Lung Diseases
- Being tested
- Probe based optical techniques
- Keywords
- Optical coherence tomography, Confocal laser endomicroscopy
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probe based optical techniquesDevice
Also called Confocal Laser Endomicroscopy (Mauna Kea technologies), Optical Coherence Tomography (St Jude medical)
During the diagnostic bronchoscopy, optical biopsy of the mucosa and alveolar compartment will be conducted by two different probe based optical techniques (Confocal Laser Endomicroscopy (Mauna Kea technologies) and Optical Coherence Tomography (St Jude Medical)). After the study measurements a biopsy will be obtained in the same area.
| Study group | Role | What they receive |
|---|---|---|
| ILD patients | ILD patients scheduled for diagnostic bronchoscopy with biopsy and/or broncho-alveolar lavage will undergo additional imagaing with probe based optical techniques. Receives: Device: Probe based optical techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describing visual characteristics on CLE-imaging and pOCT imaging of ILD.
Measured: cross sectional (1 day)
Secondary outcomes (5)
(um), size of the alveolar openings, number of cells on CLE imaging of the alveolar space (um).
Measured: cross-sectional (1 day)
Size of the alveolar openings (um), thickness of the alveolar septum/alveolar openings on pOCT imaging of the alveolar compartment (um).
Measured: cross-sectional (1day)
Feasibility of pOCT alveolar compartment: measuring number of alveoli, trajectory in OCT pull-back with alveoli (mm), number of study-related adverse events.
Measured: cross-sectional (1 day)
Correlation between pOCT imaging and histology (alveolar septum-thickness and alveolar space (um))
Measured: cross-sectional (1 day)
Correlation between pOCT imaging and histology (alveolar septum thickness (um) and alveolar compartment (mm)
Measured: cross-sectional (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start28 Oct 2015
- Primary completion22 Apr 2017
- Study completion22 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jouke T Annema, MD, PhD, Principal investigator, Netherlands, Academisch Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689102
- Sponsor's protocol ID
- NL 54612.018.15
- Status last verified
- Sep 2017
- First submitted
- 28 Jan 2016
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: CLE and OCT imaging
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy and OCT for Diagnosing ILD, a Comparison With Imaging and Pathology.
- ClinicalTrials.gov ID
- NCT02689102
- Acronym / sponsor ID
- NL 54612.018.15
- Conditions
- Interstitial Lung Diseases
- Keywords
- Optical coherence tomography, Confocal laser endomicroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 28 Oct 2015 (actual)
- Primary completion
- 22 Apr 2017 (actual)
- Study completion
- 22 Apr 2017 (actual)
- First posted
- 23 Feb 2016 (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.
Often, assessing a classifying diagnosis in patients with interstitial lung disease provides a diagnostic challenge. Currently HRCT, endoscopic or surgical video assisted thoracoscopic surgery(VATS) assessment including lung biopsies are diagnostic tools for patients with suspected ILD. However, tissue acquisition is associated with morbidity in these patients with an already compromised pulmonary function. In clinical practice this results in the fact that only a minor part of patients with an indication for tissue acquisition are actually undergoing biopsies. The aim of this study is to determine ILD-characteristics on imagign collected with minimal invasive novel optical techniques, to examine whether the addition of novel optical techniques to the diagnostic process of ILD could potentially limit the need for a tissue- (surgical) diagnosis and/or reduce the sampling error rate of biopsies by providing additional information on biopsy location.
Detailed description
Novel probe based optical techniques such as Confocal laser endomicroscopy (pCLE) and Optical coherence tomography (pOCT) are non-invasive optical techniques, compatible with conventional diagnostic bronchoscopes and provide non-invasive, real-time information on the airway wall and the alveolar compartment. Therefore, immediate validation of optical measurements during a biopsy is possible. Optical techniques might either obviate the need for an tissue biopsy or improve the diagnostic yield of conventional biopsy methods and make surgical lung biopsies that are associated with high morbidity and costs redundant.
Hypothesis: Novel optical techniques (pCLE and pOCT) provide real time information about the characteristics of the mucosa and/or the alveolar compartment in ILD.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILD patients | – | Device: Probe based optical techniquesILD patients scheduled for diagnostic bronchoscopy with biopsy and/or broncho-alveolar lavage will undergo additional imagaing with probe based optical techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of 18 years or older (n=20), who are suspected for ILD based on imaging (HRCT-scan) and with an indication for bronchoscopy with cryobiopsy.
Key inclusion criteria (2 listed)
- 18 years of age
Key exclusion criteria (3 listed)
- Smoked in the last 6 months
- Inability and willingness to provide informed consent
- Inability to comply with the study protocol
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 |
|---|---|---|
| Probe based optical techniquesAlso: Confocal Laser Endomicroscopy (Mauna Kea technologies), Optical Coherence Tomography (St Jude medical)During the diagnostic bronchoscopy, optical biopsy of the mucosa and alveolar compartment will be conducted by two different probe based optical techniques (Confocal Laser Endomicroscopy (Mauna Kea technologies) and Optical Coherence Tomography (St Jude Medical)). After the study measurements a biopsy will be obtained in the same area. | Device | ILD patients |
Primary outcome
Describing visual characteristics on CLE-imaging and pOCT imaging of ILD.
Time frame: cross sectional (1 day)
5 secondary outcomes
(um), size of the alveolar openings, number of cells on CLE imaging of the alveolar space (um).
Time frame: cross-sectional (1 day)
Size of the alveolar openings (um), thickness of the alveolar septum/alveolar openings on pOCT imaging of the alveolar compartment (um).
Time frame: cross-sectional (1day)
Feasibility of pOCT alveolar compartment: measuring number of alveoli, trajectory in OCT pull-back with alveoli (mm), number of study-related adverse events.
Time frame: cross-sectional (1 day)
Correlation between pOCT imaging and histology (alveolar septum-thickness and alveolar space (um))
Time frame: cross-sectional (1 day)
Correlation between pOCT imaging and histology (alveolar septum thickness (um) and alveolar compartment (mm)
Time frame: cross-sectional (1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Individual participant dataSharing planned: Yes. CLE and OCT imaging
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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.
Jouke T Annema, MD, PhD principal investigator
Netherlands, Academisch Medisch Centrum
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 Interstitial Lung Diseases, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 20 Sep 2017. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describing visual characteristics on CLE-imaging and pOCT imaging of ILD. (time frame: cross sectional (1 day)). 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 20 Sep 2017.