Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04671784
Status:
UNKNOWN
Last Update Posted:
2022-09-14
First Post:
2020-12-07
Brief Title:
Endoscopic Ultrasound Elastography Strain Ratio and Fractal-based Quantitative Analysis for the Mediastinal and Abdominal Lymphadenopathies
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Endoscopic Ultrasound Elastography Strain Ratio and Fractal-based Quantitative Analysis for the Mediastinal and Abdominal Lymphadenopathies
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
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:
LymphEUS01
Brief Summary:
Endoscopic ultrasound EUS and EUS-guided tissue acquisition EUS-TA are minimally invasive techniques to establish the benign or malignant nature of lymph nodes LNs with a very high accuracy In particular for mediastinal LNs a meta-analysis underlined that EUS features alone are not enough to reach a good sensitivity and specificity while EUS-TA showed a slightly high sensitivity 88 vs 85 and a significantly high specificity 96 vs 85 for diagnosing the cause of LN enlargement Considering all sites according to the meta-analysis of Xu and colleagues the assessment of LNs by EUS-elastography is a useful tool in differentiating benign and malignant LNs with a sensitivity of 88 and a specificity of 85
For lymphadenopathy of unknown origin ESGE recommends performing EUS-TA or alternatively endobronchial ultrasound EBUS-guided if the patient management requires a pathological result and no superficial lymphadenopathy is easily accessible Unfortunately EUS-TA may sometimes be challenging or inconclusive due to blood contamination or insufficient material
EUS elastography EUS-E is a non-invasive ultrasound technique that measures the hardness of tissues The level of hardness of region of interest ROI can be evaluated using qualitative scores andor quantitative methods strain ratio SR
To date most of the studies on EUS-E have been carried out using the Hitachi ultrasound machine In particular Paterson performed a quantitative analysis considering as a pathological value cut-off the SR 75 for EUS-E in the nodal staging of esophageal cancer The study involved 53 LNs using cytology as gold standard their data showed that EUS-E had a sensitivity of 83 specificity of 96 PPV of 95 and NPV of 86
Recently a new compact ultrasound processor EU-ME2 Olympus SE CO KG Hamburg Germany that includes an elastography software was developed although data regarding its application in LNs evaluation are still not available The concept of fractal geometry as a tool for describing natural objects was originally introduced by Benoit Mandelbrot A fractal can be considered as an irregularly shaped object and that can be divided into fragments each of them representing a self-similar reduced copy of the whole The hun body is an example of natural fractal as many of its parts are characterized by features resembling the typical fractal nature It has been demonstrated that fractal geometry can be used to efficiently evaluate the geometrical complexity of imaging patterns observed in oncology
The investigators recently published a study on the role of EUS elastography and fractal based analysis in the differentiation of solid pancreatic lesions However data regarding the application of fractal analysis to evaluate lymphadenopathies are still not available
For lymphadenopathy of unknown origin ESGE recommends performing EUS-TA or alternatively endobronchial ultrasound EBUS-guided if the patient management requires a pathological result and no superficial lymphadenopathy is easily accessible Unfortunately EUS-TA may sometimes be challenging or inconclusive due to blood contamination or insufficient material
EUS elastography EUS-E is a non-invasive ultrasound technique that measures the hardness of tissues The level of hardness of region of interest ROI can be evaluated using qualitative scores andor quantitative methods strain ratio SR
To date most of the studies on EUS-E have been carried out using the Hitachi ultrasound machine In particular Paterson performed a quantitative analysis considering as a pathological value cut-off the SR 75 for EUS-E in the nodal staging of esophageal cancer The study involved 53 LNs using cytology as gold standard their data showed that EUS-E had a sensitivity of 83 specificity of 96 PPV of 95 and NPV of 86
Recently a new compact ultrasound processor EU-ME2 Olympus SE CO KG Hamburg Germany that includes an elastography software was developed although data regarding its application in LNs evaluation are still not available The concept of fractal geometry as a tool for describing natural objects was originally introduced by Benoit Mandelbrot A fractal can be considered as an irregularly shaped object and that can be divided into fragments each of them representing a self-similar reduced copy of the whole The hun body is an example of natural fractal as many of its parts are characterized by features resembling the typical fractal nature It has been demonstrated that fractal geometry can be used to efficiently evaluate the geometrical complexity of imaging patterns observed in oncology
The investigators recently published a study on the role of EUS elastography and fractal based analysis in the differentiation of solid pancreatic lesions However data regarding the application of fractal analysis to evaluate lymphadenopathies are still not available
Detailed Description:
None
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