Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315439
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-03-08
Brief Title:
Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion
Sponsor:
Campus Bio-Medico University
Organization:
Campus Bio-Medico University
Study Overview
Official Title:
Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion a Multicentre Study
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Multi-RELAMI
Brief Summary:
Endoscopic ultrasound-guided EUS tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions but it is burdened by a non-negligible risk of non-diagnostic or inconclusive results
Ex-vivo fluorescence confocal laser microscopy FCM with MAVIG VivaScope 2500M-G4 could allow real time assessment of adequacy and diagnosis of the sample
Ex-vivo fluorescence confocal laser microscopy FCM with MAVIG VivaScope 2500M-G4 could allow real time assessment of adequacy and diagnosis of the sample
Detailed Description:
Endoscopic ultrasound-guided EUS tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions
However EUS-sampling is burdened by a non-negligible risk of non-diagnostic or inconclusive results with an estimated negative predictive value not higher than 70-80
ROSE could improve the diagnostic yeld of this procedure Data about the utility of rapid on-site evalutation ROSE are still controversial Without ROSE current guidelines suggest performance of three to four needle passes with an fine needle aspiration FNA needle or two to three passes with a fine needle biopsy FNB needle
Potential drawbacks of ROSE are the considerable time commitment costs and logistical and personnel issues that arise because of the on demand nature of these procedures with the need to have available technologists
Ex-vivo fluorescence confocal laser microscopy FCM is an optical technology for rapid microscopic digital imaging of fresh unfixed biological specimens without any slide preparation
FCM involves no damage or celltissue loss during the examination and the sample can subsequently be recovered and formalin-fixed and paraffin-embedded FFPE for permanent histology FCM allows both cellular and architectural details to be visualized similar to standard histological analysis of paraffin-embedded or frozen samples With FCM multimodal confocal microscopy using different laser sources and fusion images can generate optical plans similar to those from hematoxylineosin HE- stained sections directly from native tissues
Recently the feasibility of FCM with MAVIG VivaScope 2500M-G4 in EUS-FNB sample of pancreatic solid lesions has been investigated This previous single-center study demonstrated good concordance between the FCM image-based evaluation and the final FFPE histology
However in this first study a single type of FNB needle was used for all the procedures and the pathologist involved was expert in digital pathology and in pancreatic disease Therefore it might be not representative of the everyday clinical practice In addition the first study was mainly focused on the adequacy assessment of the samples
However EUS-sampling is burdened by a non-negligible risk of non-diagnostic or inconclusive results with an estimated negative predictive value not higher than 70-80
ROSE could improve the diagnostic yeld of this procedure Data about the utility of rapid on-site evalutation ROSE are still controversial Without ROSE current guidelines suggest performance of three to four needle passes with an fine needle aspiration FNA needle or two to three passes with a fine needle biopsy FNB needle
Potential drawbacks of ROSE are the considerable time commitment costs and logistical and personnel issues that arise because of the on demand nature of these procedures with the need to have available technologists
Ex-vivo fluorescence confocal laser microscopy FCM is an optical technology for rapid microscopic digital imaging of fresh unfixed biological specimens without any slide preparation
FCM involves no damage or celltissue loss during the examination and the sample can subsequently be recovered and formalin-fixed and paraffin-embedded FFPE for permanent histology FCM allows both cellular and architectural details to be visualized similar to standard histological analysis of paraffin-embedded or frozen samples With FCM multimodal confocal microscopy using different laser sources and fusion images can generate optical plans similar to those from hematoxylineosin HE- stained sections directly from native tissues
Recently the feasibility of FCM with MAVIG VivaScope 2500M-G4 in EUS-FNB sample of pancreatic solid lesions has been investigated This previous single-center study demonstrated good concordance between the FCM image-based evaluation and the final FFPE histology
However in this first study a single type of FNB needle was used for all the procedures and the pathologist involved was expert in digital pathology and in pancreatic disease Therefore it might be not representative of the everyday clinical practice In addition the first study was mainly focused on the adequacy assessment of the samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None