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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03290183
Other study ID # NL60800.018.17
Secondary ID
Status Recruiting
Phase N/A
First received August 24, 2017
Last updated September 20, 2017
Start date August 28, 2017
Est. completion date March 1, 2019

Study information

Verified date September 2017
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact L Wijmans, MD
Phone +31205667924
Email l.wijmans@amc.uva.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

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

Study Design


Intervention

Device:
Confocal laser endomicroscopy
Real-time microscopic imaging technique

Locations

Country Name City State
Netherlands Academic Medical Center Amsterdam Noordd-Holland
Netherlands NKI-AvL Amsterdam Noord-Holland

Sponsors (1)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

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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