Thymoma Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 1, 2019 |
Est. primary completion date | August 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Academic Medical Center | Amsterdam | Noordd-Holland |
Netherlands | NKI-AvL | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical feasibility: Number of successful procedures with evaluable CLE-imaging | Number of successful procedures with evaluable CLE-imaging | cross sectional (1 day) | |
Primary | Procedure-related adverse events | Number of study-related adverse events | cross sectional (1 day) | |
Primary | 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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