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Combined Needle-based Confocal Laser Endomicroscopy Cone-Beam Computed Tomography Navigation Bronchoscopy: a proof of principle study

Conditions
Peripheral lung cancer
10038666
Registration Number
NL-OMON56889
Lead Sponsor
Amsterdam UMC
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
25
Inclusion Criteria

• 18 years or older
• Suspected pulmonary nodule with an indication for CBCT-NB (decided by
multidisciplinary tumour board)
• Nodule must be solid or partially solid
• Solid part of the nodule must be at least 8 mm
• Largest dimension of the nodule on CT equal or less than 30 mm
• Ability to understand and willingness to sign a written informed consent

Exclusion Criteria

• Inability or non-willingness to provide informed consent
• Patients with an endobronchial visible lung tumor on bronchoscopic inspection
• Patients in which the target lesion is within reach of the linear EBUS scope
• Lung nodules that resolved at the time of index intraprocedural CBCT
• Failure to comply with the study protocol
• Patients with known allergy for fluorescein or risk factors for an allergic
reaction
• Pregnant or breastfeeding women
• Patients with hemodynamic instability
• Patients with refractory hypoxemia
• Patients with a therapeutic anticoagulant that cannot be held for an
appropriate interval before the procedure
• Patients who are unable to tolerate general anesthesia according to the
anesthesiologist
• Patient undergoing chemotherapy as several chemotherapies have fluorescent
properties at the same wavelength (e.g. doxorubicin)

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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