Pleural DiseasesNCT04731129
Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis
An observational study of Pleural Diseases and Pleural Neoplasms, run by University of Liege at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Diseases, Pleural Neoplasms
- What is being tested?
- Probe based confocal laser endomicroscopy of the pleura
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Dec 2020to 30 Nov 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every patient referred to the endoscopy unit for medical thoracoscopy
Who may be able to join
- Every patient referred to the endoscopy unit for medical thoracoscopy
Who cannot join
- Pregnancy
- Known allergy to the fluorescein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mini Invasive Probe Based Confocal Laser 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.
Read more
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:
- 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….)
- Cellular homogeneity is size, shape and fluorescence, as subjectively assessed by the investigator yes no
- Mean cellular size: Small: < 10µm Moderate: 10 - 20µm Large: > 20µm
- Cellular density (with reference to the Chia seed sign) Low (lower than the Chia seed sign) Moderate High
- Dysplastic vessels: Yes: (vascular leaks, tortuous or giant vessels) No: no dysplasia
- Vascular density (on a full optical area) Low: 0 -2 vessels Moderate: 3 - 4 vessels High: > 4 vessels
- Organized or anarchic connective fibers Anarchic: coarse fibers, irregular in shape, without well-defined architecture Organized : regular in shape and direction, well defined architecture.
- Chia seed sign on a full optical areal yes No
- Conditions
- Pleural Diseases, Pleural Neoplasms
- Being tested
- Probe based confocal laser endomicroscopy of the pleura
- Keywords
- Probe based confocal laser endomicroscopy
- Medical subject headings
- Pleural Diseases, Pleural Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probe based confocal laser endomicroscopy of the pleuraDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignant Pleural Infiltration Identification
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.
Measured: one day
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment.
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.
Measured: One day
Pleural Fluid Cytological Analysis
Pathological analysis of the collected pleural fluid is compared to the final histological diagnosis of pleural biopsies.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start15 Dec 2020
- Primary completion15 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pleural DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Bonhomme, University of Liege
- Investigators
- Duysinx Bernard, PhD, Study director, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731129
- Sponsor's protocol ID
- 2018-192
- Status last verified
- Nov 2024
- First submitted
- 22 Dec 2020
- Last updated
- 10 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini Invasive Probe Based Confocal Laser Endomicroscopy of the Pleura for Malignancies Diagnosis
- ClinicalTrials.gov ID
- NCT04731129
- Acronym / sponsor ID
- 2018-192
- Conditions
- Pleural Diseases, Pleural Neoplasms
- Keywords
- Probe based confocal laser endomicroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Posted 10 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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….)
- Cellular homogeneity is size, shape and fluorescence, as subjectively assessed by the investigator yes no
- Mean cellular size: Small: < 10µm Moderate: 10 - 20µm Large: > 20µm
- Cellular density (with reference to the Chia seed sign) Low (lower than the Chia seed sign) Moderate High
- Dysplastic vessels: Yes: (vascular leaks, tortuous or giant vessels) No: no dysplasia
- Vascular density (on a full optical area) Low: 0 -2 vessels Moderate: 3 - 4 vessels High: > 4 vessels
- Organized or anarchic connective fibers Anarchic: coarse fibers, irregular in shape, without well-defined architecture Organized : regular in shape and direction, well defined architecture.
- Chia seed sign on a full optical areal yes No
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient referred to the endoscopy unit for medical thoracoscopy
Key inclusion criteria (1 listed)
- Every patient referred to the endoscopy unit for medical thoracoscopy
Key exclusion criteria (2 listed)
- Pregnancy
- Known allergy to the fluorescein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probe based confocal laser endomicroscopy of the pleuraEvery 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. | Device | – |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duysinx Bernard, PhD study director
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Diseases and Pleural Neoplasms, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malignant Pleural Infiltration Identification (time frame: one day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.