Pleural Malignant MesotheliomaNCT03290183
Confocal Laser Endomicroscopy in Pleural Malignancies
An observational study of Pleural Malignant Mesothelioma and Thymoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Malignant Mesothelioma, Thymoma, Pleural Diseases
- What is being tested?
- Confocal laser endomicroscopy
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- 28 Aug 2017to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with suspected intra-thoracic malignancies, who are referred for diagnostic work-up by either transthoracic, thoracoscopic or endosonographic biopsy.
Who may be able to join
- ≥18 years of age
- Supected intra-thoracic malignancies with pleural involvement and referred for a diagnostic procedure by thoracoscopy, CT guided biopsy or endosonography
Who cannot join
- Inability and willingness to provide informed consent
- Patients with known allergy for fluorescein or risk factors for an allergic reaction
- pregnancy or lactating women
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Academic Medical Center
Amsterdam, Noordd-Holland, 1105 AZ
Lizzy Wijmans, MD, 0031205667924, l.wijmans@amc.nl
Marianne van de Pol, MD, PhD, 0205661285, m.a.vandepol@amc.nl
- Recruiting
NKI-AvL
Amsterdam, North Holland, 1066 CX
Maria Disselhorst, MD, m.disselhorst@nki.nl
Paul Baas, MD, PhD
About this study
Official title: Confocal Laser Endomicroscopy in Pleural Malignancies: A Comparison With Pathology
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.
- Conditions
- Pleural Malignant Mesothelioma, Thymoma, Pleural Diseases
- Being tested
- Confocal laser endomicroscopy
- Keywords
- Confocal laser endomicroscopy
- Medical subject headings
- Mesothelioma, Malignant, Thymoma, Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal laser endomicroscopyDevice
Also called CLE
Real-time microscopic imaging technique
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Confocal laser endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical feasibility: Number of successful procedures with evaluable CLE-imaging
Number of successful procedures with evaluable CLE-imaging
Measured: cross sectional (1 day)
Procedure-related adverse events
Number of study-related adverse events
Measured: cross sectional (1 day)
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.
Measured: cross sectional (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start28 Aug 2017
- Primary completion28 Aug 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Malignant MesotheliomaStudies 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
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jouke Annema, MD,PhD, Principal investigator, Department of respiratory medicine, Academic Medical Center Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290183
- Sponsor's protocol ID
- NL60800.018.17
- Status last verified
- Sep 2017
- First submitted
- 24 Aug 2017
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CLE imaging
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy in Pleural Malignancies: A Comparison With Pathology
- ClinicalTrials.gov ID
- NCT03290183
- Acronym / sponsor ID
- NL60800.018.17
- Conditions
- Pleural Malignant Mesothelioma, Thymoma, Pleural Diseases
- Keywords
- Confocal laser endomicroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 28 Aug 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrathoracic malignancy | – | Device: Confocal laser endomicroscopyPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected intra-thoracic malignancies, who are referred for diagnostic work-up by either transthoracic, thoracoscopic or endosonographic biopsy.
Key inclusion criteria (2 listed)
- ≥18 years of age
- Supected intra-thoracic malignancies with pleural involvement and referred for a diagnostic procedure by thoracoscopy, CT guided biopsy or endosonography
Key exclusion criteria (3 listed)
- Inability and willingness to provide informed consent
- Patients with known allergy for fluorescein or risk factors for an allergic reaction
- pregnancy or lactating women
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 |
|---|---|---|
| Confocal laser endomicroscopyAlso: CLEReal-time microscopic imaging technique | Device | Intrathoracic malignancy |
Primary outcome
Technical feasibility: Number of successful procedures with evaluable CLE-imaging
Time frame: cross sectional (1 day)
Number of successful procedures with evaluable CLE-imaging
Procedure-related adverse events
Time frame: cross sectional (1 day)
Number of study-related adverse events
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Individual participant dataSharing planned: Yes. CLE imaging
Related trials for Pleural Malignant Mesothelioma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 1
Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma
Malignant Pleural Mesothelioma (MPM)
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
Active, not recruitingPhase 3
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
Unresectable Pleural Mesothelioma
Active, not recruitingPhase 1/2
Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
Epithelioid Mesothelioma, Pleural Malignant Mesothelioma
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.
Jouke Annema, MD,PhD principal investigator
Department of respiratory medicine, Academic Medical Center Amsterdam
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Malignant Mesothelioma and Thymoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact L Wijmans, MD (+31205667924, l.wijmans@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical feasibility: Number of successful procedures with evaluable CLE-imaging (time frame: cross sectional (1 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 21 Sep 2017; AzTrials last refreshed its copy on 31 Oct 2026.