Clinical trial NCT03290183: Confocal Laser Endomicroscopy in Pleural Malignancies
Official title: Confocal Laser Endomicroscopy in Pleural Malignancies: A Comparison With Pathology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pleural Malignant Mesothelioma
Thymoma
Pleural Diseases
Keywords: Confocal laser endomicroscopy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected intra-thoracic malignancies, who are referred for diagnostic work-up by either transthoracic, thoracoscopic or endosonographic biopsy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical feasibility: Number of successful procedures with evaluable CLE-imaging
timeFrame: cross sectional (1 day)
measure: Procedure-related adverse events
timeFrame: cross sectional (1 day)
measure: To describe and develop visual descriptive image criteria (number of descriptive criteria based on CLE imaging)
timeFrame: cross sectional (1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: NKI-AvL
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noordd-Holland
Study officials:
affiliation: Department of respiratory medicine, Academic Medical Center Amsterdam
name: Jouke Annema, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: