Liver Cirrhosis
Conditions
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.
Interventions
Undergo CEUS
Sponsors
National Cancer Institute (NCI)
GE Healthcare
Bracco Diagnostics, Inc
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Specificity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval | 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. |
| Positive Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval | 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. |
| Negative Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval | 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. |
Countries
Canada, France, Italy, Switzerland, United Kingdom, United States
Outcome results
None listed