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CompletedNCT03318380Updated May 18, 2025

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

An interventional study of Dynamic Contrast-Enhanced Ultrasound Imaging in Liver Cirrhosis, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed at 11 sites in 6 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
612
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Liver Cirrhosis
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
612 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureDynamic Contrast-Enhanced Ultrasound Imaging

    Undergo CEUS

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 12 months

  2. 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.

    Time frame: Up to 12 months

  3. 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.

    Time frame: Up to 12 months

  4. 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.

    Time frame: Up to 12 months

06

Study locations

11 sites
  • University of California San Diego
    San Diego, California 92093, United States
  • Sidney Kimmel Cancer Center at Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • Albert Einstein Medical Center
    Philadelphia, Pennsylvania 19141, United States
  • Vanderbilt University
    Nashville, Tennessee 37240, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Swedish Medical Center
    Seattle, Washington 98104, United States
  • University of Calgary
    Calgary, T2N 2T9, Canada
  • University of Paris
    Paris, France
  • University of Bologna
    Bologna, 40138, Italy
  • University of Bern
    Bern, Switzerland
  • King's College Hospital
    London, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03318380
Lead sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI), GE Healthcare, Bracco Diagnostics, Inc
Responsible party
Sponsor
First posted
Oct 23, 2017
Start date
Jan 19, 2018
Primary completion
Aug 31, 2021
Completion
Nov 3, 2022
Last update
May 18, 2025

Study contacts

Andrej Lyshchik, MD, PhD
principal investigator · Sidney Kimmel Cancer Center at Thomas Jefferson University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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