Confocal Laser Endomicroscopy and Optical Coherence Tomography for Diagnosing ILD.

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Diseases
• Intervention / Treatment: Device: Probe based optical techniques

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Academisch Medisch Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

ILD patients; ILD patients scheduled for diagnostic bronchoscopy with biopsy and/or broncho-alveolar lavage will undergo additional imagaing with probe based optical techniques.

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.; Other Names: Confocal Laser Endomicroscopy (Mauna Kea technologies); Optical Coherence Tomography (St Jude medical)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Describing visual characteristics on CLE-imaging and pOCT imaging of ILD.	cross sectional (1 day)

Secondary Outcome Measures

Outcome Measure	Time Frame
(um), size of the alveolar openings, number of cells on CLE imaging of the alveolar space (um).	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).	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.	cross-sectional (1 day)
Correlation between pOCT imaging and histology (alveolar septum-thickness and alveolar space (um))	cross-sectional (1 day)
Correlation between pOCT imaging and histology (alveolar septum thickness (um) and alveolar compartment (mm)	cross-sectional (1 day)

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Jouke T Annema, MD, PhD, Netherlands, Academisch Medisch Centrum

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2015
• Primary Completion (Actual): April 22, 2017
• Study Completion (Actual): April 22, 2017

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Confocal laser endomicroscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: NL 54612.018.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: CLE and OCT imaging