Prospective Multicenter Study on Clinical Application of Sonazoid in Liver Tumor

NCT04563897 | Unknown

• 1 other identifier: S2020-300-03
• Study Type: observational
• Target: 1,300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ultrasound

Keywords

Focal liver lesions

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of contrast-enhanced ultrasound in different liver background and liver turmors by sonazoid

  10 months

Study Arms (4)

HBV/HCV

Fatty liver disease

Liver background after systematic treatment

normal hepatic background

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Interventional Ultrasound

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: October 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 25, 2020

Record last verified: 2020-09