eedle based confocal laser endomicroscopy for the diagnosis and staging of lung cancer
Recruiting
- Conditions
- ung cancer
- Registration Number
- NL-OMON21898
- Lead Sponsor
- Investigated initiated research sponsored by Mauna Kea technologies (Paris, France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
>18 years of age, (suspected) lung cancer and/or malignant mediastinal/hilar lymph nodes
Exclusion Criteria
- Inability or non-willingness to provide informed consent
- Inability to comply with the study protocol
- Patients with known allergy for fluorescein or risk factors for an allergic reaction:
- Use of beta-blocker within 24 hours before start of the bronchscopic/endosonographic procedure
- pregnancy or lactation
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility (>80% of the tumor/node needle aspirates it is possible to obtain adequate CLE video footage of the target lesion) and safety (no adverse events related to the nCLE measurements) of bronchoscopic/endosonographic (EBUS/EUS-B) guided nCLE
- Secondary Outcome Measures
Name Time Method -Create a nCLE image atlas for malignant characteristics in lung tumors and mediastinal/hilar lymph nodes.<br>-Differentiate lung tumor subtypes based on in-vivo characteristics of nCLE <br>-Assess the diagnostic value bronchoscopic/endosonographic-guided nCLE<br>