NCLE-Cone-beam CT Navigation Bronchoscopy

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help doctors find and diagnose lung nodules, which are small growths in the lungs that might indicate cancer. The study focuses on comparing two imaging techniques: one called Cone-Beam CT (CBCT) and another called nCLE, to see how well they work together in locating these nodules. Participants in this study will have a special procedure called navigation bronchoscopy, where a thin tube is inserted into the lungs to take a closer look at the nodules. The study aims to find out how often the tools used in these procedures successfully reach the nodules.

To join the study, participants need to be at least 18 years old and have a suspected lung nodule that is solid or partially solid, measuring at least 8 mm. They also need to be able to provide consent for the study. During the procedure, participants can expect two needle punctures of the nodule, followed by imaging tests to check if the tools are in the right place. It's important to note that certain individuals, such as those with specific health conditions or who are pregnant, may not be eligible to participate. Overall, this study aims to improve how doctors detect and treat lung nodules, potentially leading to better outcomes for patients.

Gender

ALL

Eligibility 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:
• • 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 in-terval 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)