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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status

Completed

Conditions

Liver Cirrhosis

Treatments

Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT03318380

1R01CA215520-01A1 (U.S. NIH Grant/Contract)

17F.310

JT 10635 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

612 patients

Sex

All

Ages

21+ years old

Volunteers

No 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.

• 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