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Completed

NCT Number: NCT04569799

Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lumason

Drug

2.4 mL per lesion

Other names: SonoVue, sulfur hexafluoride

Primary outcomes

  1. Residual Disease on CEUS Imaging.

    Time frame: 2-4 months post TACE

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

  2. Residual Disease on CT/MRI Imaging

    Time frame: 2-4 months post-TACE

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

  3. No Viable Disease on CEUS Imaging.

    Time frame: 2-4 months post-TACE

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

  4. No Viable Disease on CT/MRI Imaging.

    Time frame: 2-4 months post-TACE

    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.

Secondary outcomes

  1. Lesions Missed or Miscategorized on CEUS Imaging.

    Time frame: 4-8 months post-TACE

    Number of lesions missed or miscategorized on CEUS imaging.

  2. Lesions Missed or Miscategorized on CT/MRI Imaging.

    Time frame: 4-8 months post-TACE

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

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Acronym: TACE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 30, 2020
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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