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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Confocal laser endomicroscopy | Device | Real-time microscopic imaging technique |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with suspected intra-thoracic malignancies, who are referred for diagnostic work-up by either transthoracic, thoracoscopic or endosonographic biopsy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| L Wijmans, MD | Contact | +31205667924 | l.wijmans@amc.uva.nl | |
| M van de Pol, PhD | Contact | +31205661285 | m.a.vandepol@amc.uva.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jouke Annema, MD,PhD | Department of respiratory medicine, Academic Medical Center Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Not yet recruiting | Amsterdam | Noordd-Holland | 1105 AZ | Netherlands |
CLE imaging
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| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D013945 | Thymoma |
| D010995 | Pleural Diseases |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| NKI-AvL | Recruiting | Amsterdam | North Holland | 1066 CX | Netherlands |
|
| D009369 |
| Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018193 | Neoplasms, Complex and Mixed |
| D013953 | Thymus Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |