Confocal Laser Endomicroscopy and Optical Coherence Tomography for Diagnosing ILD.

Interstitial Lung Diseases Clinical Trial

Official title:

Confocal Laser Endomicroscopy and OCT for Diagnosing ILD, a Comparison With Imaging and Pathology.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689102
• Other study ID #: NL 54612.018.15
• Status: Completed
• Phase: N/A
• First received: January 28, 2016
• Last updated: September 19, 2017
• Start date: October 28, 2015
• Est. completion date: April 22, 2017

Study information

• Verified date: September 2017
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 22, 2017
• Est. primary completion date: April 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Diseases
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Device:
• Probe based optical techniques
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.

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describing visual characteristics on CLE-imaging and pOCT imaging of ILD.		cross sectional (1 day)
Secondary	(um), size of the alveolar openings, number of cells on CLE imaging of the alveolar space (um).		cross-sectional (1 day)
Secondary	Size of the alveolar openings (um), thickness of the alveolar septum/alveolar openings on pOCT imaging of the alveolar compartment (um).		cross-sectional (1day)
Secondary	Feasibility of pOCT alveolar compartment: measuring number of alveoli, trajectory in OCT pull-back with alveoli (mm), number of study-related adverse events.		cross-sectional (1 day)
Secondary	Correlation between pOCT imaging and histology (alveolar septum-thickness and alveolar space (um))		cross-sectional (1 day)
Secondary	Correlation between pOCT imaging and histology (alveolar septum thickness (um) and alveolar compartment (mm)		cross-sectional (1 day)