Status:
RECRUITING
NCLE-Cone-beam CT Navigation Bronchoscopy
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Lung Neoplasm
Peripheral Lung Parenchyma Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this proof of principle observational study is to investigate in patients with suspected peripheral pulmonary nodules. The main question it aims to answer is: • What is the concordance be...
Detailed Description
Lung cancer remains a significant problem in current society with one of the higher cancer related mortality rates. The increased use of chest computed tomography (CT) and the po-tential future lung c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06505642
Start Date
October 8 2024
End Date
July 1 2025
Last Update
November 13 2024
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, Netherlands