Status:
COMPLETED
Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
National Cancer Institute (NCI)
GE Healthcare
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
21+ years
Phase:
NA
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 imagi...
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2022
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT03318380
Start Date
January 19 2018
End Date
November 3 2022
Last Update
May 18 2025
Active Locations (11)
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1
University of California San Diego
San Diego, California, United States, 92093
2
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
3
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
4
Vanderbilt University
Nashville, Tennessee, United States, 37240