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OpenTrials
Completed

NCT Number: NCT04731129

Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis

Recently, probe based confocal laser endomicroscopy showed to be able to distinguish malignant from benign pleura during medical thoracoscopy. However The clinical usefulness of this new tool remains to be determined.

The investigators believe that pCLE could be part of mini invasive pleural disease management and could be used during thoracentesis in order to increase the diagnostic yield of this procedure. The investigators are starting a prospective trial to recruit patients referred for medical thoracoscopy to the endoscopy unit.

First, the pCLE probe will be introduced through the Boutin's needle or the thoracentesis catheter, just before the thoracoscopy, in order to investigate the pleural pCLE features and to identify or exclude malignant infiltration. Second those features will be compared to the pCLE acquisition obtained during the medical thoracoscopy (the probe is introduced through the working chanel of the thoracoscope), under visual control. In order to compare the invasive and mini invasive acquisition, 10 criteria will be prospectively assessed.Third, These features will be compared to the histological samples performed during thoracoscopy. Finally, the interpretation of different investigators will be compared.

The 10 criteria are presented below:

1. Abnormal tissular architecture

No: Correct identification of the previously described normal pleura characteristics Yes: identification of cellular/tissular structures which are not known to correspond to normal pleura (cellular clusters or dark clumps, glands, cells cordons, dysmorphic cells, papillar distribution….) 2. Cellular homogeneity is size, shape and fluorescence, as subjectively assessed by the investigator

yes no 3. Mean cellular size:

Small: < 10µm Moderate: 10 - 20µm Large: > 20µm 4. Cellular density (with reference to the Chia seed sign)

Low (lower than the Chia seed sign) Moderate High 5. Dysplastic vessels:

Yes: (vascular leaks, tortuous or giant vessels) No: no dysplasia 6. Vascular density (on a full optical area)

Low: 0 -2 vessels Moderate: 3 - 4 vessels High: > 4 vessels 7. Organized or anarchic connective fibers

Anarchic: coarse fibers, irregular in shape, without well-defined architecture Organized : regular in shape and direction, well defined architecture. 8. Chia seed sign on a full optical areal

yes No

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Olivier Bonhomme

Liège, 4020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Every patient referred to the endoscopy unit for medical thoracoscopy

Exclusion criteria

  • Pregnancy
  • Known allergy to the fluorescein

Treatment and study plan

Probe based confocal laser endomicroscopy of the pleura

Device

Every patient referred for medical thoracoscopy will be screened. The pCLE of the pleura will be performed 2 times. First, just before the thoracoscopy, through the Boutin's needle or the thoracentesis catheter and second through the working chanel of the pleuroscope. This last acquisition allows visual control to target the pleural endomicroscopy assessment. These two acquisitions will be compared between each other and with the histological samples of the pleuroscopy.

Primary outcomes

  1. Malignant Pleural Infiltration Identification

    Time frame: one day

    Before medical thoracoscopy, the laser endomicroscopy probe will be introduced through the Boutin's needle or the thoracentesis catheter. The pleural probe based confocal laser endomicroscopy acquisition will be assessed by two experienced and unblinded clinicians (aware of the medical history of the patient) during the procedure. The objective is to determine if the preselected criteria are present with significantly different frequencies in malignant adn in benign pleural involvement.

  2. Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment.

    Time frame: One day

    Every (Serious)adverse event will be reported during the intervention or during post intervention surveillance (1 hour post intervention).

    The feasibility will be assessed by comparing the images from the mini invasive phase with this from the invasive phase.

  3. Pleural Fluid Cytological Analysis

    Time frame: one day

    Pathological analysis of the collected pleural fluid is compared to the final histological diagnosis of pleural biopsies.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Mini Invasive Probe Based Confocal Laser Endomicroscopy of the Pleura for Malignancies Diagnosis

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 29, 2021
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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