No registrations found.
ID
Source
Brief title
Health condition
Lung cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
- Create a nCLE image atlas for malignant characteristics in lung tumors and mediastinal/hilar lymph nodes.
- Differentiate lung tumor subtypes based on in-vivo characteristics of nCLE
- Assess the diagnostic value bronchoscopic/endosonographic-guided nCLE
Background summary
Needle based confocal laser endomicroscopy (nCLE) is a high resolution imaging technique, compatible with the conventional diagnostic aspiration needles, that uses an excitation laser light to create 'real-time' microscopic images of tissues. nCLE provides real-time information of the tissue at the needle tip (smart needle). Bronchoscopic/ EBUS guided nCLE of lung tumors and intrathoracic nodes will be performed with the aim to describe CLE-characteristics for lung tumor subsets. Real-time diagnosis and staging of lung cancer might be important for future lung nodule/ staging strategies.
Study objective
We hypothesize that bronchoscopic/endosonographic (EBUS/ EUS-B) guided nCLE-imaging of lung tumors/ nodes followed by tissue sampling for the diagnosis and staging of lung cancer is feasible and safe.
Study design
2 years
Marianne van de Pol
+31 (0)20 566 1285
m.a.vandepol@amc.nl
Marianne van de Pol
+31 (0)20 566 1285
m.a.vandepol@amc.nl
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7780 |
| Other | METC Amsterdam UMC, location AMC : METC 2018_335 |