Assessing Contrast-enhanced US with Perfluorobutane Using LI-RADS to Improve Diagnostic Accuracy for Small Focal Liver Lesions: A Prospective Multicenter Study

Assessing Contrast-enhanced US with Perfluorobutane Using LI-RADS to Improve Diagnostic Accuracy for Small Focal Liver Lesions: A Prospective Study

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400086314

Enrollment

Unknown

Registered

2024-06-28

Start date

2024-03-11

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver cancer

Interventions

Gold Standard:Either histologic assessment or composite clinical and imaging reference standard

Index test:CT/MRI LI-RADS and CEUS LI-RADS based on Sonazoid

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: Risk factors for HCC: chronic hepatitis B viral infection, Liver cirrhosis, Current or prior HCC 2: Small liver lesions (=2cm) were found during routine screening or enhanced CT and MRI imaging monitoring. 3: This lesion has not been treated with HCC-related therapies in the past, including ablation, TACE, targeted drugs, and drugs in clinical trials.

Exclusion criteria

Exclusion criteria: 1: Allergy to contrast media or other contraindications 2: Refusing to sign informed consent 3: No concurrent MRI enhanced imaging examination (> 1 month apart from CEUS examination) 4: The lesion cannot be diagnosed.

Design outcomes

Primary

Measure	Time frame
Liver imaging report and data system category;	—

Secondary

Measure	Time frame
Accuracy;Sensitivity;Specificty;Positive predictive value;Negative predictive value;	—

Countries

China

Contacts

Public ContactZhou Jianhua

Sun Yat-Sen University Cancer Center

zhoujh@sysucc.org.cn+86 137 1175 7623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026