Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis

Not Applicable

Completed

• Conditions: Liver Cirrhosis
• Interventions: Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging

• Registration Number: NCT03318380
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief Summary

This clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing liver cancer in patients with cirrhosis. Diagnostic procedures, such as contrast-enhanced ultrasound imaging, may help find and diagnose liver cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the sensitivity, specificity, positive and negative predictive values of contrast-enhanced ultrasound (CEUS) for diagnosis of hepatocellular carcinoma (HCC) in patients at risk for HCC in a multicenter setting.

SECONDARY OBJECTIVES:

I. To validate CEUS Liver Imaging Reporting and Data System (LI-RADS) and determine the prevalence of HCC in each CEUS LI-RADS category.

II. To evaluate inter-reader reliability of CEUS for HCC diagnosis. III. To evaluate covariates that might limit diagnostic performance of CEUS for HCC diagnosis.

Study Timeline

• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-23
• Study Start: 2018-01-19
• Primary Completion: 2021-08-31
• Study Completion: 2022-11-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 612

Inclusion Criteria

• Capable of making informed decisions regarding his/her treatment
• Have known cirrhosis or other risk factors for HCC, based on American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL) guidelines (applicable in each site jurisdictions)
• Patients with untreated focal liver observations on liver ultrasound or multiphase contrast-enhanced CT or MRI performed as part of clinical standard of care within 4 weeks before patient enrollment.

OR

• Patients with untreated focal liver observations scheduled for follow-up multiphase contrast-enhanced CT or MRI, biopsy or surgical excision as part of clinical standard of care. CEUS should be performed within 4 weeks before or after follow-up imaging or within 4 weeks before biopsy or surgical excision.

Exclusion Criteria

• Patients who are pregnant or lactating
• Patients with focal liver observations less than 5 mm or greater than 5 cm in size
• Patients with contraindications to CEUS
• Patients with contraindications to both CT and MRI
• Patients who are medically unstable, terminally ill, or whose clinical course is unpredictable
• Liver nodule previously treated with trans-arterial or thermal ablation
• Patients who have received an investigational drug in the 30 days before CEUS, or will receive one within 72 hour after their CEUS exam

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS)	Dynamic Contrast-Enhanced Ultrasound Imaging	Patients receive sulfur hexafluoride IV and undergo CEUS imaging over 10 minutes.

Primary Outcome Measures

Name	Time	Method
Positive Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval	Up to 12 months	A value of 93% for Positive Predicative Value is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
Specificity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval	Up to 12 months	A value of 91% for specificity is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
Sensitivity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval 95% confidence interval for HCC diagnosis using CEUS LR-5 classification	Up to 12 months	A value of 67% for sensitivity is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
Negative Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval	Up to 12 months	A value of 60% for Negative predictive value is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.

Trial Locations

Locations (11)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Albert Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

University of Calgary; 🇨🇦 Calgary, Canada

University of Paris; 🇫🇷 Paris, France

University of Bologna; 🇮🇹 Bologna, Italy

University of Bern; 🇨🇭 Bern, Switzerland

King's College Hospital; 🇬🇧 London, United Kingdom

University of California San Diego; 🇺🇸 San Diego, California, United States