Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505642
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
nCLE-Cone-beam CT Navigation Bronchoscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combined Needle-based Confocal Laser Endomicroscopy Cone-Beam Computed Tomography Navigation Bronchoscopy a Proof of Principle Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this proof of principle observational study is to investigate in patients with suspected peripheral pulmonary nodules The main question it aims to answer is
What is the concordance between CBCT navigation success tool-in-lesion on CBCT spin and nCLE tool-in-lesion confirmation tool-in-lesion nCLE criteria observed
Participants scheduled to undergo a diagnostic conebeam navigation bronchoscopy will be included in the study nCLE imaging at the tip of the TBNA needle will be added to the procedure for study purposes
Two needle punctures of the pulmonary nodule will be followed by nCLE imaging directly followed by a tool-in-lesion CBCT spin in order to compare nCLE results with CBCT results
What is the concordance between CBCT navigation success tool-in-lesion on CBCT spin and nCLE tool-in-lesion confirmation tool-in-lesion nCLE criteria observed
Participants scheduled to undergo a diagnostic conebeam navigation bronchoscopy will be included in the study nCLE imaging at the tip of the TBNA needle will be added to the procedure for study purposes
Two needle punctures of the pulmonary nodule will be followed by nCLE imaging directly followed by a tool-in-lesion CBCT spin in order to compare nCLE results with CBCT results
Detailed Description:
Lung cancer remains a significant problem in current society with one of the higher cancer related mortality rates The increased use of chest computed tomography CT and the po-tential future lung cancer screening result in an increased detection of early-stage peripheral lung cancer Bronchoscopies are often indicated to collect tissue for diagnosis and to aid treatment decision making
Diagnostic bronchoscopy for peripheral lung nodules remains challenging despite many tech-nological innovations The procedure comprises three essential pillars needed for a diagnos-tic success navigation to the lesion tool-in-lesion confirmation and adequate tissue retrieval
Cone beam computed tomography navigation bronchoscopy CBCT-NB is a fairly new tech-nique that provides coarse navigation to the pulmonary lesion with real-time guidance using augmented fluoroscopy AF An initial CBCT scan allows for segmentation of the target le-sion and selecting the optimal pathway Repeated CBCT scanning allows for confirmation that the target has been reached navigation success or if repositioning is needed
Although the technique is very promising an often discussed disadvantage of CBCT is the inherent use of ionizing radiation limited availability and challenges with small nodules lo-cated in the basal and posterior fields due to respiratory motion Most procedures ask for multiple CBCT spins both for trajectory planning tool adjustments and tool-in-lesion confir-mation This combined with extensive use of fluoroscopy is associated with radiation expo-sure for both patients and the investigation team Additionally CBCT-NB with AF provides information from a global perspective rather than a local perspective In experienced centers coarse navigation guidance seems of lesser concern and fine positioning and optimal tissue sampling are the biggest problems to be overcome The persistently low diagnostic yield of navigation bronchoscopies can for the majority be attributed mispositioning of the tools in the last centimeter Therefore there is a need for complementary techniques providing real-time information for fine-tuning the needle position such as needle-based confocal laser en-domicroscopy nCLE also called the smart needle
Confocal laser endomicroscopy CLE is a high-resolution microscopic technique that visual-izes individual cells in real-time at the tip of the biopsy needle allowing for real-time micro-scopic feedback for fine tuning needle positioning and tool-in-lesion confirmation Currently it is unknown which combination of techniques are the most optimal ie leading to a high di-agnostic yield and cost-effective Therefore research is needed to investigate the potential of new combinations of techniques To date there are no reports on the combination of CBCT-NB with nCLE
Objective This study aims to investigate proof of principle of utilizing nCLE during CBCT-NB navigation bronchoscopy A confirmatory CBCT spin is considered the gold standard for tool-in-lesion but is associated with additional radiation exposure The aim is to investigate the concordance between CBCT navigation success tool-in-lesion on CBCT spin and nCLE tool-in-lesion confirmation tool-in-lesion nCLE criteria observed The investigators also hypothesize that nCLE could reduce or replace the need for additional confirmatory CBCT scans and limit fluoroscopy use
Study design Investigator-initiated proof of principle medical device study
Study population Patients 18 years and older with suspected pulmonary nodules with an indication for cone-beam computed tomography navigation bronchoscopy
Procedure Cone beam computed tomography navigation bronchoscopy combined with needle-based confocal laser endomicroscopy
Main study parametersendpoints
CBCT-NB navigation success as either tool-in-lesion OR unsuccessful
nCLE tool-in-lesion confirmation defined as tool-in-lesion nCLE criteria observed
Diagnostic bronchoscopy for peripheral lung nodules remains challenging despite many tech-nological innovations The procedure comprises three essential pillars needed for a diagnos-tic success navigation to the lesion tool-in-lesion confirmation and adequate tissue retrieval
Cone beam computed tomography navigation bronchoscopy CBCT-NB is a fairly new tech-nique that provides coarse navigation to the pulmonary lesion with real-time guidance using augmented fluoroscopy AF An initial CBCT scan allows for segmentation of the target le-sion and selecting the optimal pathway Repeated CBCT scanning allows for confirmation that the target has been reached navigation success or if repositioning is needed
Although the technique is very promising an often discussed disadvantage of CBCT is the inherent use of ionizing radiation limited availability and challenges with small nodules lo-cated in the basal and posterior fields due to respiratory motion Most procedures ask for multiple CBCT spins both for trajectory planning tool adjustments and tool-in-lesion confir-mation This combined with extensive use of fluoroscopy is associated with radiation expo-sure for both patients and the investigation team Additionally CBCT-NB with AF provides information from a global perspective rather than a local perspective In experienced centers coarse navigation guidance seems of lesser concern and fine positioning and optimal tissue sampling are the biggest problems to be overcome The persistently low diagnostic yield of navigation bronchoscopies can for the majority be attributed mispositioning of the tools in the last centimeter Therefore there is a need for complementary techniques providing real-time information for fine-tuning the needle position such as needle-based confocal laser en-domicroscopy nCLE also called the smart needle
Confocal laser endomicroscopy CLE is a high-resolution microscopic technique that visual-izes individual cells in real-time at the tip of the biopsy needle allowing for real-time micro-scopic feedback for fine tuning needle positioning and tool-in-lesion confirmation Currently it is unknown which combination of techniques are the most optimal ie leading to a high di-agnostic yield and cost-effective Therefore research is needed to investigate the potential of new combinations of techniques To date there are no reports on the combination of CBCT-NB with nCLE
Objective This study aims to investigate proof of principle of utilizing nCLE during CBCT-NB navigation bronchoscopy A confirmatory CBCT spin is considered the gold standard for tool-in-lesion but is associated with additional radiation exposure The aim is to investigate the concordance between CBCT navigation success tool-in-lesion on CBCT spin and nCLE tool-in-lesion confirmation tool-in-lesion nCLE criteria observed The investigators also hypothesize that nCLE could reduce or replace the need for additional confirmatory CBCT scans and limit fluoroscopy use
Study design Investigator-initiated proof of principle medical device study
Study population Patients 18 years and older with suspected pulmonary nodules with an indication for cone-beam computed tomography navigation bronchoscopy
Procedure Cone beam computed tomography navigation bronchoscopy combined with needle-based confocal laser endomicroscopy
Main study parametersendpoints
CBCT-NB navigation success as either tool-in-lesion OR unsuccessful
nCLE tool-in-lesion confirmation defined as tool-in-lesion nCLE criteria observed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None