NCT06079970 Confocal Laser Endomicroscopy VERification
| NCT ID | NCT06079970 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 208 participants |
| Start Date | 2023-10-18 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 208 participants in total. It began in 2023-10-18 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for malignancy. The main question\[s\] it aims to answer are: To determine if the addition of nCLE-imaging to conventional diagnostic bronchoscopic peripheral lung lesion analysis results in an improved diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis out of the total number of patients that have received the diagnostic bronchoscopic procedure). Participants will undergo diagnostic bronchoscopy either with or without the addition of nCLE imaging before each TBNA. Based on the feedback of the CLE images on (in)correct placement of the needle, the needle might be repositioned before sampling. Comparison between the diagnostic yield of these groups will be done including subgroup analysis.
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years of age 2. Suspected malignant peripheral lung lesion with an indication for a bronchoscopic diagnostic work-up as determined by the attending physician or tumor board. Peripheral pulmonary lesions are defined as lesions located beyond the visible segmental bronchi, not detectable by regular flexible bronchoscopy 3. Bronchus sign on pre-procedural CT or estimated confidence for successful navigation to the nodule resulting in a r-EBUS signal 4. Solid part of the lesion must be ≧10 mm 5. Largest dimension of lesion size on CT ≦30 mm (long-axis) 6. Ability to understand and willingness to sign a written informed consent Exclusion Criteria: 1. Inability or non-willingness to provide informed consent 2. Endobronchial visible malignancy on bronchoscopic inspection 3. Target lesion within reach of the linear EBUS scope 4. Failure to comply with the study protocol 5. Known allergy or risk factors for an allergic reaction to fluorescein 6. Pregnancy or breastfeeding 7. Hemodynamic instability 8. Refractory hypoxemia 9. Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure 10. Unable to tolerate general anesthesia according to the anesthesiologist 11. Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g., doxorubicin)
Contact & Investigator
Jouke Annema, Prof. dr.
PRINCIPAL INVESTIGATOR
Amsterdam UMC
Frequently Asked Questions
Who can join the NCT06079970 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06079970 currently recruiting?
Yes, NCT06079970 is actively recruiting participants. Contact the research team at s.vanheumen@amsterdamumc.nl for enrollment information.
Where is the NCT06079970 trial being conducted?
This trial is being conducted at New York, United States, Vienna, Austria, Prague, Czechia, Athens, Greece and 1 additional location.
Who is sponsoring the NCT06079970 clinical trial?
NCT06079970 is sponsored by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC). The principal investigator is Jouke Annema, Prof. dr. at Amsterdam UMC. The trial plans to enroll 208 participants.
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