search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lumason
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

group-1

Arm Description

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),

Outcomes

Primary Outcome Measures

Comparison of CEUS vs. LIRAD
The primary objective 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.

Secondary Outcome Measures

Compare the CEUS with CT or MRI
The second objective 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.

Full Information

First Posted
September 24, 2020
Last Updated
October 17, 2022
Sponsor
Milton S. Hershey Medical Center
Collaborators
Penn State Health Liver Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04569799
Brief Title
Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE
Acronym
TACE
Official Title
Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma (HCC) Post Transcatheter Arterial Chemoembolization (TACE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
October 11, 2022 (Actual)
Study Completion Date
October 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Penn State Health Liver Center

4. Oversight

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

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group-1
Arm Type
Other
Arm Description
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),
Intervention Type
Drug
Intervention Name(s)
Lumason
Intervention Description
2.4 mL per lesion
Primary Outcome Measure Information:
Title
Comparison of CEUS vs. LIRAD
Description
The primary objective 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.
Time Frame
2-4 months
Secondary Outcome Measure Information:
Title
Compare the CEUS with CT or MRI
Description
The second objective 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.
Time Frame
Between 4 and 8 months
Other Pre-specified Outcome Measures:
Title
Subjective data Evaluation
Description
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 )
Time Frame
2-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn McGillen
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE

We'll reach out to this number within 24 hrs