Back to resultsFusion Imaging Contrast-enhanced Ultrasound LI-RADS
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fusion imaging contrast-enhanced ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
Patients at risk for HCC(Cirrhosis or Chronic hepatitis B viral infection or Current or prior HCC) Suspicious lesions detected by CECT/MRI but not visible on conventional ultrasound and US-CECT/MRI fusion imaging Patients sign the informed consent.
Exclusion Criteria:
Patients without risk of HCC(With cirrhosis due to congenital hepatic fibrosis or With cirrhosis due to a vascular disorder such as hereditary hemorrhagic telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion, cardiac congestion, or diffuse nodular regenerative hyperplasia) Patients without a successful registration or lesions can be seen on conventional ultrasound after successful registration Pregnancy or lactation Patients with pretreat lesion Patients don't sign the informed consent.
Sites / Locations
- Tianjin Third Central Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fusion imaging contrast-enhanced ultrasound LI-RADS
Arm Description
Fusion imaging contrast-enhanced ultrasound will be performed in patients with invisible lesion at conventional ultrasound. Drug: SonoVue
Outcomes
Primary Outcome Measures
Positive predictive value
The positive predictive value = HCC in LR-5 /all lesions in LR-5
Secondary Outcome Measures
The sensitivity and specificity of CEUS LR-5
The sensitivity and specificity are calculated.
Full Information
NCT ID
NCT04955119
First Posted
July 3, 2021
Last Updated
July 3, 2021
Sponsor
Tianjin Third Central Hospital
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04955119
Brief Title
Fusion Imaging Contrast-enhanced Ultrasound LI-RADS
Official Title
Fusion Imaging Contrast-enhanced Ultrasound LI-RADS in Patients With High-risk Hepatocellular Carcinoma With Focal Liver Lesions Invisible on Conventional Ultrasound: a Multi-center Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Third Central Hospital
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
CEUS LI-RASD apply to lesion visible at precontrast ultrasound but not the lesion invisible. Fusion imaging can use to invisible lesions at precontrast ultrasound in clinical practice. Thus, our aim is to explore the application value of CEUS LI-RADS in contrast-enhanced fusion imaging for focal liver lesions that are not visible on conventional ultrasound in high-risk patients with hepatocellular carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fusion imaging contrast-enhanced ultrasound LI-RADS
Arm Type
Experimental
Arm Description
Fusion imaging contrast-enhanced ultrasound will be performed in patients with invisible lesion at conventional ultrasound.
Drug: SonoVue
Intervention Type
Diagnostic Test
Intervention Name(s)
Fusion imaging contrast-enhanced ultrasound
Intervention Description
Fusion imaging contrast-enhanced ultrasound will be performed for patients with invisible lesion at conventional ultrasound.
Drug: SonoVue
Primary Outcome Measure Information:
Title
Positive predictive value
Description
The positive predictive value = HCC in LR-5 /all lesions in LR-5
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The sensitivity and specificity of CEUS LR-5
Description
The sensitivity and specificity are calculated.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients at risk for HCC(Cirrhosis or Chronic hepatitis B viral infection or Current or prior HCC) Suspicious lesions detected by CECT/MRI but not visible on conventional ultrasound and US-CECT/MRI fusion imaging Patients sign the informed consent.
Exclusion Criteria:
Patients without risk of HCC(With cirrhosis due to congenital hepatic fibrosis or With cirrhosis due to a vascular disorder such as hereditary hemorrhagic telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion, cardiac congestion, or diffuse nodular regenerative hyperplasia) Patients without a successful registration or lesions can be seen on conventional ultrasound after successful registration Pregnancy or lactation Patients with pretreat lesion Patients don't sign the informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Jing, MD
Phone
02284112323
Ext
+86
Email
dr.jingxiang@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhou, MD
Phone
02284118101
Ext
+86
Email
zhouyan2626@163.com
Facility Information:
Facility Name
Tianjin Third Central Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300170
Country
China
12. IPD Sharing Statement
Learn more about this trial
Fusion Imaging Contrast-enhanced Ultrasound LI-RADS
We'll reach out to this number within 24 hrs