This phase II trial studies how well contrast-enhanced ultrasound (CEUS) with Lumason and Sonazoid works to identify treatment response following transarterial radioembolization (TARE) in patients with hepatocellular carcinoma (HCC). TARE is recommended for 15-25% of HCC patients. Treatment response is generally reviewed using computed tomography (CT) or magnetic resonance imaging (MRI). Identifying treatment response using CT or MRI can be challenging and identifying tumor survival is often delayed, which then delays needed re-treatment. Ultrasound imaging is a procedure in which high-energy sound waves are bounced off internal tissues or organs and make echoes. The echo patterns are shown on the screen of an ultrasound machine, forming a picture of body tissues called a sonogram. CEUS is ultrasound imaging following the administration of a microbubble contrast agent, such as Lumason or Sonazoid. These contrast agents may enhance echo pattern differences between various tissues, which may enhance the visualization of images during the ultrasound. This may be a more effective way to identify treatment response following TARE in patients with HCC.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07145801.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Thomas Jefferson University HospitalStatus: Active
Contact: John Eisenbrey
Phone: 215-503-5188
PRIMARY OBJECTIVE:
I. To evaluate the diagnostic performance of qualitative CEUS with blood-pool agents to assess treatment response of HCC to TARE.
SECONDARY OBJECTIVES:
I. To explore the use of a Kupffer cell-specific contrast agent (perflubutane microbubble [Sonazoid]) to improve diagnosis of viable HCC tumor following TARE.
II. To evaluate the diagnostic performance of dynamic quantitative CEUS to assess treatment response of HCC to TARE.
OUTLINE:
Patients undergo standard of care (SOC) CT or MRI 1-2 months and 4-6 months post-TARE. If retreatment is elected prior to 4-6 month timepoint, patients may undergo SOC angiography during retreatment. Within two weeks of each SOC imaging or retreatment, patients receive sulfur hexafluoride lipid microspheres (Lumason) intravenously (IV) and undergo CEUS over 30 minutes in the absence of unacceptable toxicity. Following a ten-minute Lumason washout period, patients then receive Sonazoid IV and undergo CEUS over 30 minutes in the absence of unacceptable toxicity.
After completion of study intervention, patients are followed up at 12 months post-TARE.
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorJohn Eisenbrey
