Confocal Laser Endomicroscopy in Pleural Malignancies

Thymoma Clinical Trial

Official title:

Confocal Laser Endomicroscopy in Pleural Malignancies: A Comparison With Pathology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03290183
• Other study ID #: NL60800.018.17
• 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
• 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

Related Conditions & MeSH terms

• Mesothelioma
• Pleural Diseases
• Pleural Malignant Mesothelioma
• Thymoma

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)