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New treatment option for Lung Cancer
Official title Confocal Laser Endomicroscopy VERification
ClinicalTrials.gov ID: NCT06079970
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years of age
- Suspected malignant peripheral lung lesion with an indication for a bronchoscopic diagnostic work-up as determined by the attending physician or...
- Bronchus sign on pre-procedural CT or estimated confidence for successful navigation to the nodule resulting in a r-EBUS signal
- Solid part of the lesion must be ≧10 mm
- Largest dimension of lesion size on CT ≦30 mm (long-axis)
You likely can't join if
- Inability or non-willingness to provide informed consent
- Endobronchial visible malignancy on bronchoscopic inspection
- Target lesion within reach of the linear EBUS scope
- Failure to comply with the study protocol
- Known allergy or risk factors for an allergic reaction to fluorescein
- Pregnancy or breastfeeding
See the full eligibility criteria
- ≥18 years of age
- 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...
- Bronchus sign on pre-procedural CT or estimated confidence for successful navigation to the nodule resulting in a r-EBUS signal
- Solid part of the lesion must be ≧10 mm
- Largest dimension of lesion size on CT ≦30 mm (long-axis)
- Ability to understand and willingness to sign a written informed consent
- Inability or non-willingness to provide informed consent
- Endobronchial visible malignancy on bronchoscopic inspection
- Target lesion within reach of the linear EBUS scope
- Failure to comply with the study protocol
- Known allergy or risk factors for an allergic reaction to fluorescein
- Pregnancy or breastfeeding
- Hemodynamic instability
- Refractory hypoxemia
- Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure
- Unable to tolerate general anesthesia according to the anesthesiologist
- Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g., doxorubicin)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Vienna, Austria
- Prague, Czechia
- Athens, Greece
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Vienna, Austria; Prague, Czechia; Athens, Greece; Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.