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Confocal Laser Endomicroscopy in Pleural Malignancies

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ClinicalTrials.gov Identifier: NCT03290183
Recruitment Status : Unknown
Verified September 2017 by Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease Intervention/treatment
Pleural Malignant Mesothelioma Thymoma Pleural Diseases Device: Confocal laser endomicroscopy

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Confocal Laser Endomicroscopy in Pleural Malignancies: A Comparison With Pathology
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : August 28, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
Device: Confocal laser endomicroscopy
Real-time microscopic imaging technique
Other Name: CLE




Primary Outcome Measures :
  1. Technical feasibility: Number of successful procedures with evaluable CLE-imaging [ Time Frame: cross sectional (1 day) ]
    Number of successful procedures with evaluable CLE-imaging

  2. Procedure-related adverse events [ Time Frame: cross sectional (1 day) ]
    Number of study-related adverse events

  3. To describe and develop visual descriptive image criteria (number of descriptive criteria based on CLE imaging) [ Time Frame: cross sectional (1 day) ]
    Qualitative description of the number of descriptive criteria based on CLE imaging.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290183


Contacts
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Contact: L Wijmans, MD +31205667924 l.wijmans@amc.uva.nl
Contact: M van de Pol, PhD +31205661285 m.a.vandepol@amc.uva.nl

Locations
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Netherlands
NKI-AvL Recruiting
Amsterdam, Noord-Holland, Netherlands, 1066 CX
Contact: Maria Disselhorst, MD       m.disselhorst@nki.nl   
Principal Investigator: Paul Baas, MD, PhD         
Academic Medical Center Not yet recruiting
Amsterdam, Noordd-Holland, Netherlands, 1105 AZ
Contact: Lizzy Wijmans, MD    0031205667924    l.wijmans@amc.nl   
Contact: Marianne van de Pol, MD, PhD    0205661285    m.a.vandepol@amc.nl   
Principal Investigator: Jouke Annema, MD PhD         
Sub-Investigator: Lizzy Wijmans, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Jouke Annema, MD,PhD Department of respiratory medicine, Academic Medical Center Amsterdam

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Responsible Party: Prof J.T. Annema, Head of pulmonary endoscopy department, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03290183     History of Changes
Other Study ID Numbers: NL60800.018.17
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: CLE imaging

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Confocal laser endomicroscopy
Additional relevant MeSH terms:
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Mesothelioma
Thymoma
Pleural Diseases
Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Neoplasms, Complex and Mixed
Thymus Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Respiratory Tract Diseases