Status:
RECRUITING
Confocal Laser Endomicroscopy VERification
Lead Sponsor:
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Collaborating Sponsors:
Mauna Kea Technologies
Conditions:
Lung Cancer
Lung Neoplasm Malignant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung ...
Detailed Description
Rationale: Lung cancer screening and the increasing use of chest-computed tomography (CT) has led to an increase in the number of (incidental) found suspected malignant lung lesions. Since tissue acqu...
Eligibility Criteria
Inclusion
- ≥18 years of age
- Suspected malignant peripheral lung lesion with an indication for a bronchoscopic diagnostic work-up as determined by the attending physician or tumor board. Peripheral pulmonary lesions are defined as lesions located beyond the visible segmental bronchi, not detectable by regular flexible bronchoscopy
- Bronchus sign on pre-procedural CT or estimated confidence for successful navigation to the nodule resulting in a r-EBUS signal
- Solid part of the lesion must be ≧10 mm
- Largest dimension of lesion size on CT ≦30 mm (long-axis)
- Ability to understand and willingness to sign a written informed consent
Exclusion
- Inability or non-willingness to provide informed consent
- Endobronchial visible malignancy on bronchoscopic inspection
- Target lesion within reach of the linear EBUS scope
- Failure to comply with the study protocol
- Known allergy or risk factors for an allergic reaction to fluorescein
- Pregnancy or breastfeeding
- Hemodynamic instability
- Refractory hypoxemia
- Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure
- Unable to tolerate general anesthesia according to the anesthesiologist
- Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g., doxorubicin)
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 18 2025
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT06079970
Start Date
October 18 2023
End Date
October 18 2025
Last Update
April 4 2025
Active Locations (7)
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1
Montefiore Medical Center
New York, New York, United States, 10467
2
Vienna General Hospital
Vienna, Austria
3
General University Hospital Prague
Prague, Czechia
4
Sotiria Hospital
Athens, Greece