To identify and define ILD characteristics with innovative imaging by confocal laser endomicroscopy (CLE), optical coherence tomography (OCT) and higher harmonic generation microscopy (HHGM)
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-To describe visual qualitative characteristics of CLE, OCT and HHGM images of
the alveolar compartment and the airway wall in ILD
-To obtain quantitative measurements of ILD by analysis of the CLE, OCT and
HHGM imaging of the alveolar compartment (size of the alveoli (um), thickness
of the alveolar septum)
-To compare the CLE, OCT and HHGM images with pathology results
-To identify specific structures and cells (i.e. collagen fibres, elastin,
inflammatory cells) on HHGM images of lung tissue
-To identify specific structures and cells (i.e. collagen fibres, elastin,
inflammatory cells) on HHGM images in ILD
Secondary outcome
-To create an image atlas with pOCT, pCLE and HHGM images of the airway wall
and alveolar compartment in ILD
-Assessing procedure-related adverse events of pCLE and pOCT
-Assessing technical feasibility of pCLE, pOCT and HHGM
-To assess the timeframe that is necessary for adequate HHGM images of lung
tissue in ILD
Background summary
Reaching classifying diagnosis in interstitial lung disease (ILD) can be a
challenge. When patients history, laboratory tests and HRCT are not sufficient
to reach confident final diagnosis the next step is tissue acquisition.
However, this means an invasive procedure with the risk of adverse events in a
vulnerable patient group. In this study we examine three novel optical
techniques to visualize lung tissue on (near)microscopic level. These
techniques have the potential to add crucial information (i.e. fibrotic versus
non-fibrotic ILD) to the multi-disciplinary team discussion and therefore
reduce the need for invasive diagnostic procedures.
Study objective
To identify and define ILD characteristics with innovative imaging by confocal
laser endomicroscopy (CLE), optical coherence tomography (OCT) and higher
harmonic generation microscopy (HHGM)
Study design
This is an investigator-initiated, observational study in 15 ILD patients
Study burden and risks
We expect patient sedation time to be prolonged by 10 minutes because of the
OCT and CLE measurements.
Based on our experiences with CLE and OCT in previous AMC initiated trials, and
literature where CLE and OCT measurements of the airway wall and alveolar
compartment are obtained, we state that imaging by CLE and OCT is safe and
poses no risk for the patient.
Images made by HHGM are ex-vivo and thereby are of no burden or risk to the
patients.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
Interstitial lung disease patients with an indication for lung tissue sampling
Exclusion criteria
* Inability and willingness to provide informed consent
* Inability to comply with study protocol
* Use of clopidogrel, or other new anti-platelet therapy, or anticoagulant
drugs that cannot be stopped temporarily
* Thrombocytopenia < 70x10^9
INR > 1.3
* Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66873.018.18 |