Confocal Laser Endomicroscopy VERification
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥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 beyond the visible segmental bronchi, not detectable by regular flexible bronchoscopy
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Neelde Based Confocal Laser Endomicroscopy
DeviceConfocal microscopy through the TBNA needle before tissue sampling using the Cellvizio system and AQ flex probe (Mauna Kea Technologies)
Conventional diagnostic bronchoscopy
Procedure/SurgeryConventional diagnostic bronchoscopy with r-EBUS and optionally fluoroscopy AND/OR EMN AND/OR VB AND/OR ultrathin scope
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: nCLE armExperimental treatment 2 interventions
Group B: Control armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic yield (intermediate definition)
Diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis \[either malignant, specific benign or non-specific benign confirmed as benign in follow-up\], relative to the total number of patients that underwent the diagnostic bronchoscopic procedure). If patients with multiple lesions are included, the diagnostic yield will be computed per nodule.
Time frame
After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years)Secondary outcomes
1
Diagnostic sensitivity
Diagnostic sensitivity for malignancy (defined as the proportion of patients in whom the bronchoscopic procedure diagnoses malignancy relative to the total number of patients with a final diagnosis of malignancy as determined by the reference standard).
Time frame
After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years)2
Diagnostic yield (strict definition)
Diagnostic yield according to the strict definition by Vachani et al.(21) (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis \[either malignant or specific benign diagnosis\], relative to the total number of patients that underwent the diagnostic bronchoscopic procedure).
Time frame
After all patients have been included (expected total time frame 2 years)3
Procedure duration
Procedure duration (from bronchoscope insertion until removal).
Time frame
During procedure (bronchoscopy)4
Proportion needle repositionings and fine-tuning
Percentage of patients in which the needle was fine-tuned (defined as moving the needle within the same distal airway) or repositioned (defined as the selection of a different distal airway for tissue sampling) based on nCLE feedback (defined as the number of patients the needle was fine-tuned/repositioned divided by the total number of patients in which nCLE imaging was used).
Time frame
During procedure (bronchoscopy)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor institution
Mauna Kea Technologies
Collaborator
Source ClinicalTrials.gov