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

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Dynamic Contrast-Enhanced Ultrasound Imaging
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Cirrhosis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Diego
  • Sidney Kimmel Cancer Center at Thomas Jefferson University
  • Albert Einstein Medical Center
  • Vanderbilt University
  • University of Texas Southwestern Medical Center
  • Swedish Medical Center
  • University of Calgary
  • University of Paris
  • University of Bologna
  • University of Bern
  • King's College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS)

Arm Description

Patients receive sulfur hexafluoride IV and undergo CEUS imaging over 10 minutes.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2017
Last Updated
November 16, 2022
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI), GE Healthcare, Bracco Diagnostics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03318380
Brief Title
Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis
Official Title
Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
November 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI), GE Healthcare, Bracco Diagnostics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
612 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS)
Arm Type
Experimental
Arm Description
Patients receive sulfur hexafluoride IV and undergo CEUS imaging over 10 minutes.
Intervention Type
Procedure
Intervention Name(s)
Dynamic Contrast-Enhanced Ultrasound Imaging
Intervention Description
Undergo CEUS
Primary Outcome Measure Information:
Title
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
Description
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
Title
Specificity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval
Description
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
Title
Positive Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval
Description
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
Title
Negative Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Lyshchik, MD, PhD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Calgary
City
Calgary
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of Paris
City
Paris
Country
France
Facility Name
University of Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
University of Bern
City
Bern
Country
Switzerland
Facility Name
King's College Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

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