Confocal Laser Endomicroscopy in Pleural Malignancies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Confocal Laser Endomicroscopy in Pleural Malignancies: A Comparison With Pathology

Conditions
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Pleural Malignant Mesothelioma, Thymoma, Pleural Diseases

Intervention / Treatment
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* Device: Confocal laser endomicroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intrathoracic malignancy<br>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<br>* Real-time microscopic imaging technique<br>* Other names: CLE;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Confocal laser endomicroscopy