Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE (TACE)

Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma (HCC) Post Transcatheter Arterial Chemoembolization (TACE)

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

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Lumason

Detailed Description

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
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group-1; Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS),	Drug: Lumason; 2.4 mL per lesion; Other Names: SonoVue; sulfur hexafluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	2-4 months post-TACE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesions Missed or Miscategorized on CEUS Imaging.	Number of lesions missed or miscategorized on CEUS imaging.	4-8 months post-TACE
Lesions Missed or Miscategorized on CT/MRI Imaging.	Number of lesions missed or miscategorized on CT/MRI imaging.	4-8 months post-TACE

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective data Evaluation	The third objective 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 about your preferences and experience with CEUS and modality preference, graded on a Likert scale1 - 7 (1 = not at all, 7 = max )	2-4 months

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Penn State Health Liver Center
• Investigators: Principal Investigator: Kathryn McGillen, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): October 11, 2022
• Study Completion (Actual): October 11, 2022

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: STUDY14930

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes