Confocal Laser Endomicroscopy in Pleural Malignancies

Confocal Laser Endomicroscopy in Pleural Malignancies: A Comparison With Pathology

To date, the different biopsy methods, such as CT-guided pleural biopsy, mediastinal biopsy, endosonography and thoracoscopy have their limitations in diagnosing pleural malignancies, such as mesothelioma. Sampling errors frequently occur resulting in the common histological finding of 'non-specific pleuritic/fibrosis', which presents a great uncertainty for clinicians and patients. Confocal laser endomicroscopy (CLE) provides real-time imaging on a cellular level, however data of CLE in pleural malignancies are lacking.

Study Overview

• Status: Unknown
• Conditions: Pleural Diseases; Thymoma; Pleural Malignant Mesothelioma
• Intervention / Treatment: Device: Confocal laser endomicroscopy

Detailed Description

Novel optical imaging techniques such as confocal laser endomicroscopy (CLE) have emerged in recent years as techniques that actually enable in vivo real-time microscopic analysis of malignancies of the GI-tract and lung cancer. Through recent advances the probe became small enough to fit through a biopsy needle and can be used during CT-guided and endosonographic guided biopsies (EUS-FNA). Patients with intra-thoracic malignancies often require invasive procedures such as bronchoscopy, thoracoscopy, mediastinoscopy, transthoracic needle aspiration or surgical exploration to obtain a diagnosis. Intra thoracic malignancies encompass lung cancers, thymomas and malignant pleural mesothelioma. These tumors often present with pleural thickening, unilateral pleural effusion, mediastinal enlargement or a peripheral located mass in the lungs. Tissue collection of the suspected pleural thickening is required to assess a diagnosis and differentiate between the tumor types, to classify and to stage in a proper manner. To date, the different biopsy methods, such as CT-guided pleural biopsy, mediastinal biopsy, endosonography and thoracoscopy have their limitations in diagnosing these malignancies. Sampling errors frequently occur resulting in the common histological finding of 'non-specific pleuritic/fibrosis', which presents a great uncertainty for clinicians and patients. Novel microscopic imaging techniques such as CLE are capable of real time imaging on a cellular level. Data of CLE in intra-thoracic malignancies are lacking.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066 CX
      • Recruiting
      • NKI-AvL
      • Contact: Maria Disselhorst, MD; Email: m.disselhorst@nki.nl
      • Principal Investigator: Paul Baas, MD, PhD
  • Noordd-Holland
    • Amsterdam, Noordd-Holland, Netherlands, 1105 AZ
      • Not yet recruiting
      • Academic Medical Center
      • Sub-Investigator: Lizzy Wijmans, MD
      • Contact: Lizzy Wijmans, MD; Phone Number: 0031205667924; Email: l.wijmans@amc.nl
      • Contact: Marianne van de Pol, MD, PhD; Phone Number: 0205661285; Email: m.a.vandepol@amc.nl
      • Principal Investigator: Jouke Annema, MD PhD

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 with suspected intra-thoracic malignancies, who are referred for diagnostic work-up by either transthoracic, thoracoscopic or endosonographic biopsy.

Description

Inclusion Criteria:

• ≥18 years of age
• Supected intra-thoracic malignancies with pleural involvement and referred for a diagnostic procedure by thoracoscopy, CT guided biopsy or endosonography

Exclusion Criteria:

• Inability and willingness to provide informed consent
• Patients with known allergy for fluorescein or risk factors for an allergic reaction
• pregnancy or lactating women

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intrathoracic malignancy; Patients with (strong suspicion of) intrathoracic malignancy and an indication for tissue collection by CT-guided, transthoracic or thoracoscopic approach undergo additional imaging with confocal laser endomicroscopy (CLE).	Device: Confocal laser endomicroscopy; Real-time microscopic imaging technique; Other Names: CLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical feasibility: Number of successful procedures with evaluable CLE-imaging	Number of successful procedures with evaluable CLE-imaging	cross sectional (1 day)
Procedure-related adverse events	Number of study-related adverse events	cross sectional (1 day)
To describe and develop visual descriptive image criteria (number of descriptive criteria based on CLE imaging)	Qualitative description of the number of descriptive criteria based on CLE imaging.	cross sectional (1 day)

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Jouke Annema, MD,PhD, Department of respiratory medicine, Academic Medical Center Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Anticipated): August 28, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Confocal laser endomicroscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Neoplasms, Complex and Mixed; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Thymus Neoplasms; Thymoma; Mesothelioma; Mesothelioma, Malignant; Pleural Diseases
• Other Study ID Numbers: NL60800.018.17

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No