Using advanced imaging techniques to improve lung cancer diagnosis
Combined Needle-based Confocal Laser Endomicroscopy Cone-Beam Computed Tomography Navigation Bronchoscopy: a Proof of Principle Study
This study is testing a new imaging method to see if it can help doctors better diagnose lung cancer in patients with suspicious lung nodules.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | chemotherapy, doxorubicin, radiation |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06505642 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of cone beam computed tomography (CBCT) navigation combined with needle-based confocal laser endomicroscopy (nCLE) in diagnosing peripheral lung nodules. Participants scheduled for diagnostic bronchoscopy will undergo two needle punctures of the pulmonary nodule, followed by nCLE imaging and a CBCT spin to assess the accuracy of the navigation technique. The study seeks to determine the concordance between the navigation success and the confirmation of tool-in-lesion using nCLE. This innovative approach may enhance diagnostic accuracy for lung cancer at an early stage.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with suspected solid or partially solid pulmonary nodules that meet specific size criteria.
Not a fit: Patients with visible endobronchial tumors or those whose nodules have resolved prior to the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for lung cancer, enabling earlier and more effective treatment.
How similar studies have performed: While the use of CBCT navigation in bronchoscopy is promising, this specific combination with nCLE is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Jouke Annema, MD, PhD — Amsterdam UMC
- Study coordinator: Jouke Annema, MD, PhD
- Email: j.t.annema@amsterdamumc.nl
- Phone: +31(0)20 566 2694
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.