Prospective Multicenter Study on Clinical Application of Sonazoid in Liver Tumor

Contrast-enhanced Ultrasound in Liver Tumor by Sonazoid

Sonazoid as a new generation of ultrasound contrast agent.This study based on the features of Sonazoid specific angiography and his mechanical index, the role of Sonazoidin in the differential diagnosis of benign and malignant focal liver lesions in different liver background was explored

Study Overview

• Status: Unknown
• Conditions: Ultrasound

Detailed Description

Sonazoid as a new generation of ultrasound contrast agent, was liver specificity (Kupffer cells), macrophages at the very stable period, Kupffer imaging contrast enhancement effect for more than 1 hour, it is mainly used for focal liver lesions of blood vessels and Kupffer phase of ultrasonic imaging, facilitate early detection of small lesions (< 1 cm). Until now, Sonazoid has been mainly focused on liver focal lesions.

Most liver cancer patients in China are associated with chronic liver disease, and more than 80% of liver disease patients are in advanced stage at the time of treatment. Differential diagnosis is still a challenge for enhanced CT / MRI. About 40% of HCCs lack arterial phase enhancement and 40% - 60% of small lesions do not show elution in venous phase. The existing imaging methods have low sensitivity in detecting small lesions, and it is difficult to detect lesions smaller than 1 cm. Studies have found that the sensitivity of CT and MRI is of 60 - 94.4% and 58.5 - 93% respectively when the tumor diameter is larger than 1 cm. When the tumor diameter is less than 1 cm, the sensitivity of CT and MRI to detect tumors is reduced to 33 - 45% and 33 - 67%, respectively. The diagnostic efficiency of conventional ultrasonography for small lesions, especially in patients with chronic hepatitis B or cirrhosis, is poor. Although the diagnostic efficiency of conventional contrast-enhanced ultrasound in the diagnosis of small lesions with chronic hepatitis B or liver cirrhosis has a certain improvement, there is still a large rate of missed diagnosis. In addition, ordinary ultrasound, conventional contrast-enhanced ultrasound, CT and MRI are very poor in the diagnosis of liver cancer differentiation, especially for highly differentiated liver cancer.

Sonazoid is a second generation ultrasound contrast agent, which is composed of microbubbles containing chemically stable and insoluble Perfluorobutane (PFB) gas and a hard shell of phosphatidylserine sodium (2-3 μ m in diameter) wrapped in the outer layer. These microbubbles can generate stable nonlinear oscillations in a low-power acoustic field and generate echoes at the second harmonic frequency of the transmitted pulse for enhanced contrast harmonic imaging . In addition to the ability of real-time angiography, Sonazoid microbubbles can be engulfed by Kupffer cells in the intrahepatic reticuloendothelial system to produce liver parenchymal imaging Usually 10 minutes after intravenous injection of Sonazoid contrast agent, Kupffer phase image appears, and normal liver parenchyma is enhanced . Therefore, at this stage, malignant lesions with little or no Kupffer cells are clearly demonstrated due to the lack of contrast media. In addition, because Sonazoid microbubbles can resonate without rupture under moderate ultrasonic pressure, Kupffer phase (Kupffer phase) imaging can be stable for more than several hours, which is beneficial to whole liver scanning . Because Sonazoid has the advantages of ultra long time development and good stability, Sonazoid has significant clinical advantages in the diagnosis of small liver cancer lesions, liver cirrhosis background liver cancer and highly differentiated liver cancer.. However, these studies based on Sonazoid are all small sample studies and subjective qualitative differential diagnosis methods, and lack of systematic analysis and research. Therefore, based on the advantages of the new ultrasound contrast agent, using qualitative analysis and quantitative analysis method to collect large samples, systematically explore the standardized diagnosis scheme and diagnostic efficiency of liver cancer with different liver background, which has important clinical significance for early diagnosis, early detection and improving the accuracy of diagnosis of liver cancer.

• Study Type: Observational
• Enrollment (Anticipated): 1300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with definite liver neoplastic lesions, containing multiple kinds of liver background

Description

Inclusion Criteria:

• 1.Chinese citizen, ≥ 18 years old; 2.Conventional ultrasound shows that there is definite lesion in the liver, and there is liver parenchyma around the lesion; 3.There is enhanced MRI or enhanced CT finding. For patients with liver fibrosis after hepatitis, the results of liver parenchyma elastography can be added (optional); 4. If the subjects are female, they should be non pregnant and lactating women; 5.Patients voluntarily participate in the study and signe informed consent

Exclusion Criteria:

• 1.Subjects are known to be allergic to Perfluorobutane or any component of Sonazoid; 2.Patients with severe heart disease or severe lung disease; 3.Pregnant, potential pregnant or lactating patients; 4.No enhanced MRI or CT results are available; 5.The researchers consider that the subjects are not suitable for this study

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
HBV/HCV
Fatty liver disease
Liver background after systematic treatment
normal hepatic background

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic performance of contrast-enhanced ultrasound in different liver background and liver turmors by sonazoid	10 months

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Focal liver lesions
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: S2020-300-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No