Evaluating a new imaging technique for lung cancer diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.