Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE

Milton S. Hershey Medical Center26 enrolled

Overview

The purpose of this research study is to find out if a different type of imaging study called contrast enhanced ultrasound (CEUS) is as good as, or better than CT or MRI in patients diagnosed with hepatocellular carcinoma (HCC) after receiving TACE treatment

This is 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. All patients will receive standard of care CT/MRI and will also get a contrast ultrasound to directly compare. Timepoint 0- Our proposed study population includes subjects with diagnosed HCC, who are treated with TACE. Patients will be identified and enrolled at the time of initial TACE. Timepoint 1- Following initial TACE, patients will receive a CT or MRI, as routinely ordered in the post-TACE setting, to assess for residual or new HCC. At this same imaging follow-up visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS). Timepoint 2- Per standard clinical care, patients typically return for repeat imaging (CT/MRI) within 2-4 months following the first imaging visit.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

LumasonDRUG

2.4 mL per lesion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult (≥18 years of age) patients with diagnosed HCC (via imaging, biopsy, or combination of imaging and biochemical markers), who are treated with their first round of TACE. * Sex: male or female * BMI ≤ 40 Exclusion Criteria: * Children (\<18), pregnant patients * Patients who do not speak English * Patients with a history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason. * Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) * Patients who have a prior non-contrast ultrasound, within last 3 months (at time of consent), where the tumor could not be seen - most commonly due to severe steatosis or obesity. * Pregnant or nursing woman * Patients who do not plan to get their follow-up CT/MRI at Hershey Medical Center.

Locations (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Residual Disease on CEUS Imaging.

Number of lesions with residual disease identified on CEUS imaging. Residual disease is defined as enhancement within the lesion using CEUS.

Time frame: 2-4 months post TACE

Residual Disease on CT/MRI Imaging

Number of lesions with residual disease identified on CT/MRI imaging. Residual disease is defined as enhancement within the lesion using CT/MRI.

Time frame: 2-4 months post-TACE

No Viable Disease on CEUS Imaging.

Number of lesions with no viable disease identified on CEUS imaging. Non-viable disease is defined as no enhancement within the lesion using CEUS.

Time frame: 2-4 months post-TACE

No Viable Disease on CT/MRI Imaging.

Number of lesions with no viable disease identified on CT/MRI imaging. Non-viable disease is defined as no enhancement within the lesion using CT/MRI.

Time frame: 2-4 months post-TACE

Secondary Outcomes

Lesions Missed or Miscategorized on CEUS Imaging.

Number of lesions missed or miscategorized on CEUS imaging.

Time frame: 4-8 months post-TACE

Lesions Missed or Miscategorized on CT/MRI Imaging.

Number of lesions missed or miscategorized on CT/MRI imaging.

Time frame: 4-8 months post-TACE

Data from ClinicalTrials.gov

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