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Protocol Summary


Protocol No.
PSCI-20-088
Prinicipal Investigator
McGillen, Kathryn
Phase
N/A
Age Group
Adult
Scope
Local
Secondary Protocol No.
PSCI 20-088
Title
Accuracy of Contrast-Enhanced Ultrasound for hepatocellular carcinoma (HCC) post transcatheter arterial chemoembolization (TACE)
Objective
Study Objectives

In this study, we propose a prospective trial to determine if contrast enhanced ultrasound (CEUS) is non-inferior to CT or MRI in patients with hepatocellular carcinoma (HCC) following transcatheter arterial chemoembolization (TACE) treatments, in a U.S. population, using Lumason contrast agent. This would be the largest trial to date examining this patient population in the U.S.

The first aim of our study is to compare the sensitivity and specificity of the two studies (Research Timepoint 1) to evaluate for non-inferiority between CEUS and the clinical gold standard of CT/MRI using the Liver Reporting & Data System (LIRAD). We will be assessing the presence of treated or residual tumor, new sites of disease, and portal vein thrombus. Patient factors, such as BMI, underlying liver disease type, alpha fetoprotein level, and size of liver will be recorded. If findings of metastatic disease external to the liver are identified on CT or MRI and not seen on CEUS, they will be recorded.

The second aim of the project will compare the CEUS with a second, standard of care, follow-up CT or MRI (performed 2-4 months later [Research Timepoint 2]). CT can have false negatives due to ethiodol obscuring subtle, early disease and it is possible that CEUS could identify residual disease earlier compared to the gold standards, but would be characterized as a false positive if compared only to the initial imaging (Timepoint 1). This follow-up will evaluate for false positives or negatives on any of the modalities.

The third aim of the project will evaluate patient subjective data in regards to imaging modality preference and possible effects on compliance. The survey will be administered at the conclusion of Timepoint 1 and will include questions about anxiety, comfort, compliance, and modality preference, graded on a Likert scale.

Applicable Disease Sites
Liver
Status
Open
Participating Institutions
Hershey Medical Center