Confocal Laser Endomicroscopy in Pleural Malignancies
- Conditions
- ThymomaPleural Malignant MesotheliomaPleural Diseases
- Interventions
- Device: Confocal laser endomicroscopy
- Registration Number
- NCT03290183
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- ≥18 years of age
- Supected intra-thoracic malignancies with pleural involvement and referred for a diagnostic procedure by thoracoscopy, CT guided biopsy or endosonography
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intrathoracic malignancy Confocal laser endomicroscopy 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).
- Primary Outcome Measures
Name Time Method Procedure-related adverse events cross 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.
Technical feasibility: Number of successful procedures with evaluable CLE-imaging cross sectional (1 day) Number of successful procedures with evaluable CLE-imaging
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Academic Medical Center
🇳🇱Amsterdam, Noordd-Holland, Netherlands
NKI-AvL
🇳🇱Amsterdam, Noord-Holland, Netherlands