Evaluating a new imaging technique for lung cancer diagnosis
Bronchoscopy With and Without Needle-based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis: Protocol for a Multicenter Randomized Controlled Trial (CLEVER Trial)
This study is testing a new imaging technique during lung procedures to see if it helps doctors diagnose lung cancer more accurately in patients with suspicious lung lesions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | chemotherapy, doxorubicin |
| Locations | 5 sites (New York, New York and 4 other locations) |
| Trial ID | NCT06079970 on ClinicalTrials.gov |
What this trial studies
This multi-center randomized clinical trial aims to assess the effectiveness of needle-based confocal laser endomicroscopy (nCLE) in enhancing the diagnostic yield of bronchoscopic procedures for patients with peripheral lung lesions suspected of malignancy. Participants will undergo standard diagnostic bronchoscopy either with or without nCLE imaging, which provides real-time microscopic images of tissues during the procedure. The study seeks to determine if the integration of nCLE can improve the accuracy of diagnosing lung cancer by allowing for better needle placement and sampling. By comparing outcomes between the two groups, the trial will evaluate the added value of this innovative imaging technique.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspected malignant peripheral lung lesions requiring bronchoscopic evaluation.
Not a fit: Patients with visible malignancies on bronchoscopic inspection or those whose lesions are accessible via linear EBUS scope may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of lung cancer, enabling timely and appropriate treatment for patients.
How similar studies have performed: Previous studies have shown promising results with similar imaging techniques, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
New York, New York and 4 other locations
- Montefiore Medical Center — New York, New York, United States (Recruiting)
- Vienna General Hospital — Vienna, Austria (Recruiting)
- General University Hospital Prague — Prague, Czechia (Recruiting)
- Sotiria Hospital — Athens, Greece (Recruiting)
- Amsterdam University Medical Centers — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Jouke Annema, Prof. dr. — Amsterdam UMC
- Study coordinator: Saskia van Heumen, MSc
- Email: s.vanheumen@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.