Peripheral lung cancer
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CBCT-NB navigation success: tool-in-lesion OR unsuccessful navigation nCLE tool-in-lesion confirmation: in-lesion nCLE criteria seen | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Technical feasibility: proportion of nCLE imaging that are successful (meaning that the preloaded needle can be advanced through the working channel, puncture the nodule, advance the CLE probe and start imaging) resulting good quality images (feasibility meaning >90% good quality interpretable images). This is based on previous nCLE studies where nCLE was employed during conventional bronchoscopy and >85% of images were of good quality. 2. Safety: number of (severe) adverse events ((S)AEs) and investigational proce-dure-related adverse events (AEs) (<4% severe adverse events (1/25) will be con-sidered acceptable). Pneumothorax is one of the most common reported compli-cation of endobronchial procedures with transbronchial needle aspiration and biop-sies and occurs between 1-6% of CBCT-NB procedures. Often, medical interven-tional such as chest tube placement is not needed. Intraproce-dural haemorrhage requiring medical intervention will also be reported based on the CTCAE and is also reported in ~4-5% of cases. 3. Diagnostic yield: the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis out of the total number of patients that have re-ceived the diagnostic bronchoscopic procedure. 4. Diagnostic sensitivity for malignancy: defined as the proportion of patients that have malignancy diagnosed by bronchoscopic tissue sampling, relative to the total number of patients with a final diagnosis of malignancy as determined by the ref-erence standard. 5. Sensitivity, specificity and accuracy of real-time nCLE imaging assessment, meaning identification of the known nCLE criteria (malignancy, granuloma, air-way/lung parenchyma) 6. Sensitivity, specificity and accuracy of post-procedure nCLE image assessment, meaning identification of the known nCLE criteria (malignancy, granuloma, air-way/lung parenchyma) 7. Interobserver agreement (IOA) and intraobserver reliability (IOR) or the post-procedure nCLE image assessment 8. Total p | — |
Countries
Netherlands
Outcome results
None listed