Trial Title:
Confocal Laser Endomicroscopy VERification
NCT ID:
NCT06079970
Condition:
Lung Cancer
Lung Neoplasm Malignant
Carcinoma, Non-Small-Cell Lung
Neoplasm of Lung
Conditions: Official terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Conditions: Keywords:
Confocal Microscopy
Bronchoscopy
Confocal laser endomicroscopy
CLE
Fluoroscopy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Neelde Based Confocal Laser Endomicroscopy
Description:
Confocal microscopy through the TBNA needle before tissue sampling using the Cellvizio
system and AQ flex probe (Mauna Kea Technologies)
Arm group label:
nCLE arm
Intervention type:
Procedure
Intervention name:
Conventional diagnostic bronchoscopy
Description:
Conventional diagnostic bronchoscopy with r-EBUS and optionally fluoroscopy AND/OR EMN
AND/OR VB AND/OR ultrathin scope
Arm group label:
Control arm
Arm group label:
nCLE arm
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.
Detailed description:
Rationale: Lung cancer screening and the increasing use of chest-computed tomography (CT)
has led to an increase in the number of (incidental) found suspected malignant lung
lesions. Since tissue acquisition for pathological analysis is prerequisite for diagnosis
and optimal treatment, a drastic increase in the number of patients that need to undergo
bronchoscopy is expected.
Over 70% of the suspected lesions develop in the periphery of the lung and are therefore
not visible during conventional bronchoscopy. Although several bronchoscopic navigational
techniques demonstrated an improved navigation towards the target lesion, the diagnostic
yield remains suboptimal due to a substantial near-miss rate. As a result, the need for
complementary bronchoscopic guidance that provides real-time feedback on the correct
positioning of the biopsy instruments is urgent.
Needle-based Confocal laser endomicroscopy (nCLE) is a novel high-resolution imaging
technique that uses an excitation laser light to create 'real-time' microscopic images of
tissues. nCLE can be integrated into the biopsy needle, allowing real-time cancer
detection at the tip of the biopsy needle during bronchoscopy. The confocal microscope
captures autofluorescence of tissues or, combined with intravenously (IV) infused
fluorophores (such as fluorescein) allows imaging of individual tumor cells. Recent
studies on nCLE-imaging in lung tumors and metastatic lymph nodes have identified and
validated nCLE criteria for malignancy (enlarged pleomorphic cells, dark clumps and
directional streaming) and airway/lung parenchyma (alveoli, elastin fibres of the
conducting airway, bronchial epithelium and still image) and granulomas. A recent study
demonstrated that these nCLE-criteria can be used in real-time to fine-tune the needle
positioning during ongoing bronchoscopy and thereby potentially improve the diagnostic
yield.
This randomized controlled trials aims to evaluate the added value of nCLE-imaging (smart
needle) to the conventional used bronchoscopic approach for peripheral lung lesion
analysis.
Objective: This multicenter, randomized controlled trial, aims to investigate if
nCLE-imaging integrated with conventional bronchoscopy results in a higher diagnostic
yield compared to conventional bronchoscopy without nCLE in the diagnosis of peripheral
lung nodules.
Study design: Investigator-initiated, international, multi-center randomized controlled
trial including university and general hospitals.
Study population: Patients (>18 years old) with suspected malignant peripheral lung
lesions with an indication for bronchoscopic analysis.
Procedure: Bronchoscopy will be performed according to institutional practice, including
radial endobronchial ultrasound (r-EBUS) and optionally fluoroscopy, electromagnetic
navigation, virtual bronchoscopy and/or ultrathin bronchoscopy. This is followed by
transbronchial needle aspiration (TBNA) and (cryo-)biopsies (control arm). In the study
arm, nCLE-imaging will be added prior to TBNA tissue acquisition to fine-tune the
sampling area. Cytology staining for rapid onsite evaluation (ROSE) and cellblock will be
performed according to local practice.
Primary objective:
To determine if the addition of nCLE-imaging to conventional 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).
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Montefiore Medical Center
Address:
City:
New York
Zip:
10467
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Ali Sadoughi, MD, DAABIP
Investigator:
Last name:
Ali Sadoughi, MD, DAABIP
Email:
Principal Investigator
Facility:
Name:
Vienna General Hospital
Address:
City:
Vienna
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Daniela Gompelmann, Prof.
Investigator:
Last name:
Daniela Gompelmann
Email:
Principal Investigator
Investigator:
Last name:
Christina Bal
Email:
Sub-Investigator
Facility:
Name:
General University Hospital Prague
Address:
City:
Prague
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Zuzana Šestáková
Investigator:
Last name:
Jirí Votruba
Email:
Sub-Investigator
Investigator:
Last name:
Zuzana Šestáková
Email:
Principal Investigator
Facility:
Name:
Sotiria Hospital
Address:
City:
Athens
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Grigoris Stratakos, MD, PhD
Investigator:
Last name:
Nektarios Anagnostopoulos
Email:
Sub-Investigator
Investigator:
Last name:
Evangelia Koukaki
Email:
Sub-Investigator
Investigator:
Last name:
Grigoris Stratakos
Email:
Principal Investigator
Investigator:
Last name:
Katerina Bakiri
Email:
Sub-Investigator
Facility:
Name:
Morgagni Pierantoni Hospital
Address:
City:
Forlì
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Venerino Poletti, Prof.
Contact backup:
Last name:
Claudia Ravaglia
Investigator:
Last name:
Venerino Poletti, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Claudia Ravaglia
Email:
Sub-Investigator
Facility:
Name:
Amsterdam University Medical Centers
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Saskia van Heumen, MSc
Contact backup:
Last name:
Jouke Annema, Prof. dr.
Investigator:
Last name:
Jouke Annema
Email:
Principal Investigator
Investigator:
Last name:
Saskia van Heumen
Email:
Sub-Investigator
Investigator:
Last name:
Peter Bonta
Email:
Sub-Investigator
Investigator:
Last name:
Johannes Daniels
Email:
Sub-Investigator
Investigator:
Last name:
Marjolein Heuvelmans
Email:
Sub-Investigator
Facility:
Name:
KSW Kantonsspital Winterthur
Address:
City:
Winterthur
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Jürgen Hetzel, Prof.
Investigator:
Last name:
Jürgen Hetzel
Email:
Principal Investigator
Investigator:
Last name:
Maik Haentschel
Email:
Sub-Investigator
Start date:
October 18, 2023
Completion date:
October 18, 2025
Lead sponsor:
Agency:
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Agency class:
Other
Collaborator:
Agency:
Mauna Kea Technologies
Agency class:
Industry
Source:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06079970
