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

Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging

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 Type: Interventional
• Enrollment (Actual): 612
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Calgary, Canada, T2N 2T9
    • University of Calgary
• France
  • Paris, France
    • University of Paris
• Italy
  • Bologna, Italy, 40138
    • University of Bologna
• Switzerland
  • Bern, Switzerland
    • University of Bern
• United Kingdom
  • London, United Kingdom
    • King's College Hospital
• United States
  • California
    • San Diego, California, United States, 92093
      • University of California San Diego
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University
  • Tennessee
    • Nashville, Tennessee, United States, 37240
      • Vanderbilt University
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS); Patients receive sulfur hexafluoride IV and undergo CEUS imaging over 10 minutes.	Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging; Undergo CEUS

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborators: National Cancer Institute (NCI); GE Healthcare; Bracco Diagnostics, Inc
• Investigators: Principal Investigator: Andrej Lyshchik, MD, PhD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

Helpful Links

• Thomas Jefferson University Hospital
• Sidney Kimmel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2018
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): November 3, 2022

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 17F.310

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No