Confocal Laser Endomicroscopy in Pleural Malignancies
1 other identifier
observational
20
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2017
CompletedStudy Start
First participant enrolled
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
September 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedSeptember 21, 2017
September 1, 2017
1 year
August 24, 2017
September 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Technical feasibility: Number of successful procedures with evaluable CLE-imaging
Number of successful procedures with evaluable CLE-imaging
cross sectional (1 day)
Procedure-related adverse events
Number of study-related adverse events
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.
cross sectional (1 day)
Study Arms (1)
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).
Interventions
Real-time microscopic imaging technique
Eligibility Criteria
Patients with suspected intra-thoracic malignancies, who are referred for diagnostic work-up by either transthoracic, thoracoscopic or endosonographic biopsy.
You may qualify if:
- ≥18 years of age
- Supected intra-thoracic malignancies with pleural involvement and referred for a diagnostic procedure by thoracoscopy, CT guided biopsy or endosonography
You may not qualify if:
- Inability and willingness to provide informed consent
- Patients with known allergy for fluorescein or risk factors for an allergic reaction
- pregnancy or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Academic Medical Center
Amsterdam, Noordd-Holland, 1105 AZ, Netherlands
NKI-AvL
Amsterdam, North Holland, 1066 CX, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jouke Annema, MD,PhD
Department of respiratory medicine, Academic Medical Center Amsterdam
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of pulmonary endoscopy department
Study Record Dates
First Submitted
August 24, 2017
First Posted
September 21, 2017
Study Start
August 28, 2017
Primary Completion
August 28, 2018
Study Completion
March 1, 2019
Last Updated
September 21, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share
CLE imaging