Pleural CarcinomatosisNCT03805971
Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.
An observational study of Pleural Carcinomatosis, run by University of Liege at 1 site in Belgium.
Trial summary
Probe based confocal laser endomicroscopy (pCLE) is a new optical endoscopic technique, generating fluorescent light emission from the tissue of interest and allowing in vivo live imaging at a cellular level ("optical biopsies"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Carcinomatosis
- What is being tested?
- Study of the pleural cavity with a confocal laser endomicroscope.
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 65 participants
- Where
- 1 siteBelgium
- Study dates
- 22 May 2018to 1 Dec 2019
- 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 refered for a medical thoracoscopy and willing to participate.
Who may be able to join
- Every patient refered for a medical thoracoscopy and willing to participate.
Who cannot join
- < 18 ans
Trial locations and contacts
1 site in 1 country.
About this study
Probe based confocal laser endomicroscopy (pCLE) is a new optical endoscopic technique, generating fluorescent light emission from the tissue of interest and allowing in vivo live imaging at a cellular level ("optical biopsies"). It was first used in gastroenterology and came later to the light in pulmonary medicine and is still an experimental technique. In gastroenterology, this new investigational technique is used in Barret oesophagus, inflammatory bowel disease, pancreas cystic lesions... Nowadays, there are no data concerning usefulness of endomicroscopy in medical thoracoscopy. During thoracoscopy This new tool could help to target biopsies or help clinicians to do the right diagnosis early, allowing rapid therapeutic intervention (talc pleurodesis for example) . Furthermore, some details can be studied only during live imaging as microorganisms or bloodflows. The investigators performed an endomicroscopy to every patient needing a thoracoscopy (no matter the indication) and who agreed to participate. The pCLE features between malignant and benign pleura were compared in order to find specific criteria for malignant infiltration.
- Conditions
- Pleural Carcinomatosis
- Being tested
- Study of the pleural cavity with a confocal laser endomicroscope.
- Keywords
- pCLE, confocal laser endomicroscopy, pleural carcinomatosis, mesothelioma, optical biopsies
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of the pleural cavity with a confocal laser endomicroscope.Device
Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.
| Study group | Role | What they receive |
|---|---|---|
| patient aged more than 18 years admitted for thoracoscopy | Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies Receives: Device: Study of the pleural cavity with a confocal laser endomicroscope. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table
Measured: One day.
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.
Here are presented Mean cell size and maximum vascular diameter
Measured: One day
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.
Quantitative criteria are presented in this table. Here is presented the mean cellular density
Measured: One day
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.
Quantitative criteria are presented in this table. Here is presented the vascular density.
Measured: One day
Secondary outcomes (1)
Quality of the pCLE Acquisition
The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.
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 posted16 Jan 2019
- Study start22 May 2018
- Primary completion15 Oct 2019
- Study completion1 Dec 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural CarcinomatosisStudies 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
- 65 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
- Olivier Bonhomme, MD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805971
- Sponsor's protocol ID
- B707201837069
- Status last verified
- Mar 2020
- First submitted
- 13 Jan 2019
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonhomme O, Heinen V, Detrembleur N, Corhay JL, Louis R, Duysinx B. Probe-based confocal laser endomicroscopy for pleural malignancies diagnosis. Respirology. 2021 Feb;26(2):188-195. doi: 10.1111/resp.13945. Epub 2020 Oct 1.
PubMed 33001538
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.
- ClinicalTrials.gov ID
- NCT03805971
- Acronym / sponsor ID
- B707201837069
- Conditions
- Pleural Carcinomatosis
- Keywords
- pCLE, confocal laser endomicroscopy, pleural carcinomatosis, mesothelioma, optical biopsies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Posted 3 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Probe based confocal laser endomicroscopy (pCLE) is a new optical endoscopic technique, generating fluorescent light emission from the tissue of interest and allowing in vivo live imaging at a cellular level ("optical biopsies"). It was first used in gastroenterology and came later to the light in pulmonary medicine and is still an experimental technique. In gastroenterology, this new investigational technique is used in Barret oesophagus, inflammatory bowel disease, pancreas cystic lesions... Nowadays, there are no data concerning usefulness of endomicroscopy in medical thoracoscopy. During thoracoscopy This new tool could help to target biopsies or help clinicians to do the right diagnosis early, allowing rapid therapeutic intervention (talc pleurodesis for example) . Furthermore, some details can be studied only during live imaging as microorganisms or bloodflows. The investigators performed an endomicroscopy to every patient needing a thoracoscopy (no matter the indication) and who agreed to participate. The pCLE features between malignant and benign pleura were compared in order to find specific criteria for malignant infiltration.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient aged more than 18 years admitted for thoracoscopy | – | Device: Study of the pleural cavity with a confocal laser endomicroscope.Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient refered for a medical thoracoscopy and willing to participate.
Key inclusion criteria (1 listed)
- Every patient refered for a medical thoracoscopy and willing to participate.
Key exclusion criteria (1 listed)
- < 18 ans
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 |
|---|---|---|
| Study of the pleural cavity with a confocal laser endomicroscope.Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool. | Device | patient aged more than 18 years admitted for thoracoscopy |
Primary outcome
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Time frame: One day.
Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Time frame: One day
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura. Here are presented Mean cell size and maximum vascular diameter
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Time frame: One day
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura. Quantitative criteria are presented in this table. Here is presented the mean cellular density
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Time frame: One day
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura. Quantitative criteria are presented in this table. Here is presented the vascular density.
1 secondary outcome
Quality of the pCLE Acquisition
Time frame: One day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33001538Bonhomme O, Heinen V, Detrembleur N, Corhay JL, Louis R, Duysinx B. Probe-based confocal laser endomicroscopy for pleural malignancies diagnosis. Respirology. 2021 Feb;26(2):188-195. doi: 10.1111/resp.13945. Epub 2020 Oct 1.
- 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.
Olivier Bonhomme, MD principal investigator
Centre Hospitalier Universitaire de 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 Carcinomatosis, 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 1 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 3 Apr 2020. 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 3 Apr 2020). 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?
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria. (time frame: One day.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03805971, which also lists 1 linked publication.
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 3 Apr 2020.