RecruitingNCT06590948

Clinical Application of Quantitative Major Imaging Features of CEUS LI-RADS

Clinical Application of Quantitative Major Imaging Features of Contrast-enhanced Ultrasound Liver Imaging Reporting and Data System


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

50 participants

Start Date

Jul 5, 2024

Study Type

OBSERVATIONAL

Conditions

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 improved.LI-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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether specific measurements taken during a contrast-enhanced ultrasound scan (CEUS) can help doctors better classify liver lesions and distinguish liver cancer (hepatocellular carcinoma, or HCC) from other growths. It is a non-interventional imaging study — no new treatments are given. **You may be eligible if...** - You are at high risk for HCC (e.g., you have liver cirrhosis, chronic Hepatitis B, a history of HCC, or have had a liver transplant) - You had both a CEUS scan and a contrast-enhanced CT or MRI scan within 2 months of your surgery - You have confirmed pathology results (from surgery or biopsy) - Your imaging and clinical data are complete **You may NOT be eligible if...** - You are under 18 - Your liver cirrhosis is caused by unusual conditions such as congenital liver fibrosis or liver vascular diseases - You received chemotherapy, immunotherapy, or local tumor treatments before the imaging - The quality of your imaging or pathology data is poor or incomplete Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTcontrast-enhanced ultrasound

contrast-enhanced ultrasound with SonoVue and quantitative analysis of liver imaging reporting and data system


Locations(1)

Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06590948


Related Trials