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Confocal Laser Endomicroscopy in Pleural Malignancies

NCT ID: NCT03290183

Last Updated: 2017-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-28

Study Completion Date

2019-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pleural Malignant Mesothelioma Thymoma Pleural Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

Confocal laser endomicroscopy

Intervention Type DEVICE

Real-time microscopic imaging technique

Interventions

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Confocal laser endomicroscopy

Real-time microscopic imaging technique

Intervention Type DEVICE

Other Intervention Names

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CLE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Prof J.T. Annema

Head of pulmonary endoscopy department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jouke Annema, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of respiratory medicine, Academic Medical Center Amsterdam

Locations

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Academic Medical Center

Amsterdam, Noordd-Holland, Netherlands

Site Status NOT_YET_RECRUITING

NKI-AvL

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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L Wijmans, MD

Role: CONTACT

[email protected]
+31205667924

M van de Pol, PhD

Role: CONTACT

[email protected]
+31205661285

Facility Contacts

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Lizzy Wijmans, MD

Role: primary

[email protected]
0031205667924

Marianne van de Pol, MD, PhD

Role: backup

[email protected]
0205661285

Maria Disselhorst, MD

Role: primary

[email protected]

Other Identifiers

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NL60800.018.17

Identifier Type: -

Identifier Source: org_study_id