Cirrhosis, Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, cirhossi, Contrast-enhanced ultrasound, LI-RADS
Brief summary
The new version of CEUS LI-RADS published at 2018(version 2017). In this study, the investigators aim to investigate the diagnosing performance of CEUS LI-RADS by administrating different contrast agents (SonoVue/ Sonazoid).
Detailed description
Independent radiologists from department of ultrasound will report their diagnosing results according to CEUS LI-RADS version 2017 without getting any information about patients. The researcher of this subject will collect all results and evaluated the sensitivity and specificity of CEUS LI-RADS and the diagnosing performance with different contrast agents.
Interventions
DRUGSonovue and Sonazoid
Subjects were randomized to receive SonoVue firstly and Sonazid secondly after wash out period. Between the wash out period(at least 30min) and after whole trial, the patients was carefully observed at our department for at least 30min. contast agent dose: Sonazoid (0.12 μL/kg of perflubutane microbubbles) or SonoVue (2.4 mL) in a 1:1 ratio.
DRUGSonazoid and Sonovue
Subjects were randomized to receive Sonazoid firstly and SonoVue secondly after wash out period. Between the wash out period(at least 30min) and after whole trial, the patients was carefully observed at our department for at least 30min. contast agent dose: Sonazoid (0.12 μL/kg of perflubutane microbubbles) or SonoVue (2.4 mL) in a 1:1 ratio.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The sequence of sonovue or sonazoid is blind to participant. The data is blind to the radiologist who is plan to evalutaed the data using CEUS LIRADS version 2017 and the outcome assessor who calculated all data and do the statistical calculation.
Intervention model description
included patients receive both SonoVue and Sonazoid with a randomized crossover design. The wash out period is at least 30min to make sure the fore-inject contrast agent is clear in blood.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients at risk for HCC with focal liver lesion on conventional ultrasound. * history of cirrhosis. * historty of HBV infection.
Exclusion criteria
* systemic therapy with sorafenib * pretreat lesion * patients don't sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CEUS LI-RADS Grades of SonoVue and Sonazoid agents in enrolled patients. | 6 months | CEUS LI-RADS® v2017 which is published by ACR is a standardized system for technique, interpretation, reporting, and data collection for contrast-enhanced ultrasound exams in patients at risk for developing HCC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The sensitivity and specificity of CEUS-LI-RADS by different contrast agencies. | 6 months | The sensitivity and specificity are calculated using parameters such as ture postive, false positive, Ture negative, false negetive. |
Countries
China
Outcome results
None listed