Needle based CLE -EBUS guided- for diagnosis and staging of lung cancer

Needle based CLE -EBUS guided- for diagnosis and staging of lung cancer - nCLE in lungcancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48172

Enrollment

Registered

2019-04-30

Start date

2019-05-06

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 mediastinal metastases

Interventions

bronchoscopy

confocal laser endomicroscopy

EBUS

lungcancer

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - >18 years of age - Suspected or tissue proven lung tumor and/or suspected malignant mediastinal/hilar lymph nodes within reach of EBUS-TBNA

Exclusion criteria

Exclusion criteria: - Inability and 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 betablokker within 24 hours before start of the EBUS-TBNA procedure - possible pregnancy or lactating women

Design outcomes

Primary

Measure	Time frame
- To test the feasibility and safety of bronchoscopic/endosonography guided nCLE	—

Secondary

Measure	Time frame
- Assess the diagnostic value of bronchoscopy/endosonography guided nCLE - Develop an CLE image atlas for malignant characteristics in mediastinal/hilar lymph nodes and peripheral lung tumors. - Differentiate tumor types based on in-vivo characteristics of nCLE	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)