Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE

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.

• Lumason (Drug), also known as SonoVue, sulfur hexafluoride: 2.4 mL per lesion

Primary outcomes

• Residual Disease on CEUS Imaging. [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.
• Residual Disease on CT/MRI Imaging [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.
• No Viable Disease on CEUS Imaging. [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.
• No Viable Disease on CT/MRI Imaging. [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

• Lesions Missed or Miscategorized on CEUS Imaging. [4-8 months post-TACE]: Number of lesions missed or miscategorized on CEUS imaging.
• Lesions Missed or Miscategorized on CT/MRI Imaging. [4-8 months post-TACE]: Number of lesions missed or miscategorized on CT/MRI imaging.

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Residual Disease on CEUS Imaging. (Primary), Number, lesions: Group-1 19
• Residual Disease on CT/MRI Imaging (Primary), Number, lesions: Group-1 17
• No Viable Disease on CEUS Imaging. (Primary), Number, lesions: Group-1 12
• No Viable Disease on CT/MRI Imaging. (Primary), Number, lesions: Group-1 16
• Lesions Missed or Miscategorized on CEUS Imaging. (Secondary), Number, lesions: Group-1 2
• Lesions Missed or Miscategorized on CT/MRI Imaging. (Secondary), Number, lesions: Group-1 6

Adverse events

Time frame: Up to 8 months (length of time subjects were on study)

Limitations and caveats: Small sample number, pilot study

• Study Protocol and Statistical Analysis Plan (PDF, 2021-11-03)
• Informed Consent Form (PDF, 2021-11-03)

• Kathryn McGillen, Principal investigator, Milton S. Hershey Medical Center