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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318380
• Other study ID #: 17F.310
• Status: Completed
• Phase: N/A
• Start date: January 19, 2018
• Est. completion date: November 3, 2022

Study information

• Verified date: November 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 612
• Est. completion date: November 3, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Procedure:
• Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo CEUS

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary
France	University of Paris	Paris
Italy	University of Bologna	Bologna
Switzerland	University of Bern	Bern
United Kingdom	King's College Hospital	London
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Vanderbilt University	Nashville	Tennessee
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of California San Diego	San Diego	California
United States	Swedish Medical Center	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	Bracco Diagnostics, Inc, GE Healthcare, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital