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Confocal Laser Endomicroscopy in Pleural Malignancies

Confocal Laser Endomicroscopy in Pleural Malignancies: A Comparison With Pathology

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03290183
Enrollment
20
Registered
2017-09-21
Start date
2017-08-28
Completion date
2019-03-01
Last updated
2017-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Diseases, Pleural Malignant Mesothelioma, Thymoma

Keywords

Confocal laser endomicroscopy

Brief summary

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.

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.

Interventions

DEVICEConfocal laser endomicroscopy

Real-time microscopic imaging technique

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Netherlands

Contacts

Primary ContactL Wijmans, MD
l.wijmans@amc.uva.nl+31205667924
Backup ContactM van de Pol, PhD
m.a.vandepol@amc.uva.nl+31205661285

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026