Needle based confocal laser endomicroscopy for the diagnosis and staging of lung cancer

Needle based confocal laser endomicroscopy (nCLE) for diagnosing lung cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21898

Enrollment

Registered

2019-06-04

Start date

2019-05-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: >18 years of age, (suspected) lung cancer and/or malignant mediastinal/hilar lymph nodes

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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	—

Contacts

Public ContactMarianne van de Pol

Amsterdam UMC, locatie AMC, afdeling Longziekten

m.a.vandepol@amc.nl+31 (0)20 566 1285

Outcome results