Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE

Penn State Health

Status and phase: Completed; Phase 4

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Lumason

Study type: Interventional

Funder types: Other

Identifiers

NCT04569799

STUDY14930

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

group-1

Other group

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),

Treatment:

Drug: Lumason