Fusion Imaging Contrast-enhanced Ultrasound LI-RADS
1 other identifier
interventional
132
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hepatocellular-carcinoma
Started Jul 2021
Shorter than P25 for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2021
CompletedFirst Posted
Study publicly available on registry
July 8, 2021
CompletedStudy Start
First participant enrolled
July 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJuly 8, 2021
July 1, 2021
5 months
July 3, 2021
July 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Positive predictive value
The positive predictive value = HCC in LR-5 /all lesions in LR-5
6 months
Secondary Outcomes (1)
The sensitivity and specificity of CEUS LR-5
6 months
Study Arms (1)
Fusion imaging contrast-enhanced ultrasound LI-RADS
EXPERIMENTALFusion imaging contrast-enhanced ultrasound will be performed in patients with invisible lesion at conventional ultrasound. Drug: SonoVue
Interventions
Fusion imaging contrast-enhanced ultrasound will be performed for patients with invisible lesion at conventional ultrasound. Drug: SonoVue
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300170, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2021
First Posted
July 8, 2021
Study Start
July 30, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
July 8, 2021
Record last verified: 2021-07