Clinical trial NCT02689102: Confocal Laser Endomicroscopy and Optical Coherence Tomography for Diagnosing ILD.
Official title: Confocal Laser Endomicroscopy and OCT for Diagnosing ILD, a Comparison With Imaging and Pathology.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Diseases
Keywords: Optical coherence tomography
Confocal laser endomicroscopy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age

  * Supected ILD and referred for diagnostic bronchoscopic procedure with cryobiopsy

Exclusion Criteria:

* Smoked in the last 6 months
* Inability and willingness to provide informed consent
* Inability to comply with the study protocol

Primary outcomes:
measure: Describing visual characteristics on CLE-imaging and pOCT imaging of ILD.
timeFrame: cross sectional (1 day)
Secondary outcomes:
measure: (um), size of the alveolar openings, number of cells on CLE imaging of the alveolar space (um).
timeFrame: cross-sectional (1 day)
measure: Size of the alveolar openings (um), thickness of the alveolar septum/alveolar openings on pOCT imaging of the alveolar compartment (um).
timeFrame: cross-sectional (1day)
measure: Feasibility of pOCT alveolar compartment: measuring number of alveoli, trajectory in OCT pull-back with alveoli (mm), number of study-related adverse events.
timeFrame: cross-sectional (1 day)
measure: Correlation between pOCT imaging and histology (alveolar septum-thickness and alveolar space (um))
timeFrame: cross-sectional (1 day)
measure: Correlation between pOCT imaging and histology (alveolar septum thickness (um) and alveolar compartment (mm)
timeFrame: cross-sectional (1 day)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
state: Noord-Holland
Study officials:
affiliation: Netherlands, Academisch Medisch Centrum
name: Jouke T Annema, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: