Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079970
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-10-02
Brief Title:
Confocal Laser Endomicroscopy VERification
Sponsor:
Amsterdam University Medical Centers UMC Location Academic Medical Center AMC
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Bronchoscopy With and Without Needle-based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis Protocol for a Multicenter Randomized Controlled Trial CLEVER Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEVER
Brief 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 questions 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 incorrect 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
The main questions 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 incorrect 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 airwaylung 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 andor 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
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 airwaylung 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None