CClinicalTrials.gg
Status unknownNCT03290183Updated Sep 21, 2017

Confocal Laser Endomicroscopy in Pleural Malignancies

An observational study in Pleural Malignant Mesothelioma, Thymoma and Pleural Diseases, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Status unknown at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-21.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pleural Malignant Mesothelioma
  • Thymoma
  • Pleural Diseases

Keywords

  • Confocal laser endomicroscopy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceConfocal laser endomicroscopy

    Real-time microscopic imaging technique

    Also known as: CLE

05

What researchers measure

Primary outcomes

  1. Technical feasibility: Number of successful procedures with evaluable CLE-imaging

    Number of successful procedures with evaluable CLE-imaging

    Time frame: cross sectional (1 day)

  2. Procedure-related adverse events

    Number of study-related adverse events

    Time frame: cross sectional (1 day)

  3. 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.

    Time frame: cross sectional (1 day)

06

Study locations

1 of 2 sites recruiting
  • NKI-AvL
    Amsterdam, Noord-Holland 1066 CX, Netherlands
    • Maria Disselhorst, MD · Contact · m.disselhorst@nki.nl
    • Paul Baas, MD, PhD · Principal investigator
    Recruiting
  • Academic Medical Center
    Amsterdam, Noordd-Holland 1105 AZ, Netherlands
    • Lizzy Wijmans, MD · Contact · l.wijmans@amc.nl · 0031205667924
    • Marianne van de Pol, MD, PhD · Contact · m.a.vandepol@amc.nl · 0205661285
    • Jouke Annema, MD PhD · Principal investigator
    • Lizzy Wijmans, MD · Sub investigator
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: Yes — CLE imaging

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03290183
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Responsible party
Prof J.T. Annema (Head of pulmonary endoscopy department, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
Sep 21, 2017
Start date
Aug 28, 2017
Primary completion
Aug 28, 2018 (estimated)
Completion
Mar 1, 2019 (estimated)
Last update
Sep 21, 2017

Study contacts

L Wijmans, MD
Contact
l.wijmans@amc.uva.nl
+31205667924
M van de Pol, PhD
Contact
m.a.vandepol@amc.uva.nl
+31205661285
Jouke Annema, MD,PhD
principal investigator · Department of respiratory medicine, Academic Medical Center Amsterdam

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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