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

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ClinicalTrials.gov Identifier: NCT03318380
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : April 24, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
GE Healthcare
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Thomas Jefferson University ( 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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 640 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 [ Time Frame: 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.

  2. Specificity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval [ Time Frame: 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.

  3. Positive Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval [ Time Frame: 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.

  4. Negative Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval [ Time Frame: 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318380


Contacts
Contact: Andrej Lyshchik, MD, PhD 215-503-0587 Andrej.Lyshchik@jefferson.edu

Locations
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92093
Contact: Yuko Kono, MD       ykono@ucsd.edu   
Principal Investigator: Yuko Kono, MD         
United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Andrej Lyshchik, MD, PhD       Andrej.Lyshchik@jefferson.edu   
Albert Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Shuchi Rodgers, MD    215-456-3439    rodgersS@einstein.edu   
Principal Investigator: Shuchi Rodgers, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37240
Contact: Geoffrey Wile, MD       geoffrey.wile@vanderbilt.edu   
Principal Investigator: Geoffrey Wilde, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Lisa Finch, MD       lisa.finch@swedish.org   
Principal Investigator: Lisa Finch, MD         
Canada
University of Calgary Recruiting
Calgary, Canada, T2N 2T9
Contact: Stephanie Wilson, MD       stephanie.wilson@ahs.ca   
Principal Investigator: Stephanie Wilson, MD         
Italy
University of Bologna Recruiting
Bologna, Italy, 40138
Contact: Fabio Piscaglia, MD       fabio.piscaglia@unibo.it   
Principal Investigator: Fabio Piscaglia, MD         
United Kingdom
King's College Hospital Not yet recruiting
London, United Kingdom
Contact: Paul Sidhu, MD       paulsidhu@nhs.net   
Principal Investigator: Paul Sidhu         
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
National Cancer Institute (NCI)
GE Healthcare
Bracco Diagnostics, Inc
Investigators
Principal Investigator: Andrej Lyshchik, MD, PhD Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03318380     History of Changes
Other Study ID Numbers: 17F.310
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases