Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06590948
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Clinical Application of Quantitative Major Imaging Features of CEUS LI-RADS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Application of Quantitative Major Imaging Features of Contrast-enhanced Ultrasound Liver Imaging Reporting and Data System
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Liver cancer LC is the sixth most common malignant tumor and the third cause of cancer mortality in the world According to the 2018 United States Association for the Study of Liver Diseases guidelines for the diagnosis and treatment of liver cancer patients with HCC high-risk factors can be directly diagnosed by imaging if they have typical imaging signs without the need for puncture pathological confirmation
Since 2011 United States the American College of Radiology ACR has successively launched Liver Imaging And Reporting and Data System LI-RADS based-on contrast-enhanced CT CECT contrast-enhanced MRI CEMRI and contrast-enhanced ultrasound CEUS which have achieved good clinical diagnostic results and are constantly being updated and improvedLI-RADS provides standardized imaging diagnosis for high-risk populations and classifies each liver lesion into LR-1 to LR-5 possibility of HCC LR-M probably or definitely malignant but not HCC LR-TIV intravenous tumor
Although CEUS LR-5 has a high accuracy in diagnosing HCC there is also a considerable proportion of HCC in CEUS LR-4 and CEUS LR-3 Studies have shown that CEUS LR-M contains a high proportion of HCC the sensitivity of CEUS LR-5 in diagnosing HCC is relatively low and the possibility of HCC cannot be ruled out if it is not classified as CEUS LR-5 Therefore how to improve the diagnostic sensitivity and specificity is the key goal of CEUS LI-RADS
According to the CEUS LI-RADS diagnostic criteria the key signs include arterial phase hyper-enhancement APHE and washout The guidelines divide washout into an early and late washout with 60 seconds after contrast agent injection If the lesion present with a completely black hole within 2 minutes it is classified as marked washout otherwise it is mild washout The current judgment of the degree of washout is based on the subjective decision made by the observer subjectively which cannot distinguish the subtle differences in the image and has a subjective dependence The consistency among the observers is uneven which affects the diagnostic efficiency of CEUS LI-RADS Based on this the purpose of this study was to quantify the key parameters of CEUS LI-RADS Washout Onset and Washout Degree and propose standardized and objective diagnostic criteria to reduce the differences between observers and further improve its diagnostic sensitivity for high-risk groups of HCC
Since 2011 United States the American College of Radiology ACR has successively launched Liver Imaging And Reporting and Data System LI-RADS based-on contrast-enhanced CT CECT contrast-enhanced MRI CEMRI and contrast-enhanced ultrasound CEUS which have achieved good clinical diagnostic results and are constantly being updated and improvedLI-RADS provides standardized imaging diagnosis for high-risk populations and classifies each liver lesion into LR-1 to LR-5 possibility of HCC LR-M probably or definitely malignant but not HCC LR-TIV intravenous tumor
Although CEUS LR-5 has a high accuracy in diagnosing HCC there is also a considerable proportion of HCC in CEUS LR-4 and CEUS LR-3 Studies have shown that CEUS LR-M contains a high proportion of HCC the sensitivity of CEUS LR-5 in diagnosing HCC is relatively low and the possibility of HCC cannot be ruled out if it is not classified as CEUS LR-5 Therefore how to improve the diagnostic sensitivity and specificity is the key goal of CEUS LI-RADS
According to the CEUS LI-RADS diagnostic criteria the key signs include arterial phase hyper-enhancement APHE and washout The guidelines divide washout into an early and late washout with 60 seconds after contrast agent injection If the lesion present with a completely black hole within 2 minutes it is classified as marked washout otherwise it is mild washout The current judgment of the degree of washout is based on the subjective decision made by the observer subjectively which cannot distinguish the subtle differences in the image and has a subjective dependence The consistency among the observers is uneven which affects the diagnostic efficiency of CEUS LI-RADS Based on this the purpose of this study was to quantify the key parameters of CEUS LI-RADS Washout Onset and Washout Degree and propose standardized and objective diagnostic criteria to reduce the differences between observers and further improve its diagnostic sensitivity for high-risk groups of HCC
Detailed Description:
None
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