This early phase I trial studies how well contrast-enhanced ultrasound scan with Lumason microbubbles works in predicting tumor response before, during and after liver artery embolization in patients with liver cancer. Lumason microbubble is a contrast agent that is used to evaluate the liver. Contrast-enhanced ultrasound with Lumason microbubbles may help determine an early response to radioembolization and/or help demonstrate radiation toxicity to the surrounding liver.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04150874.
PRIMARY OBJECTIVE:
I. Prospectively acquire dynamic contrast-enhanced ultrasound (CEUS) scans following intravenous (IV) administration of sulfur hexafluoride lipid microspheres (Lumason microbubbles) in 25 patients with primary or secondary (metastatic) tumors in the liver and compute time intensity curves from tumor regions of interest (ROIs) to predict tumor response to transarterial yttrium Y-90 (Y90) radioembolization.
SECONDARY OBJECTIVE:
I. Predict toxicity from hepatic artery embolization (HAE) by quantitative analysis of CEUS time-intensity curves computed from 2 ROIs: peritumoral rim of “at-risk” parenchyma (< 1.5 cm from tumor), and normal liver parenchyma > 1.5 cm outside the tumor rim.
OUTLINE:
Patients receive Lumason microbubbles IV, then undergo CEUS prior to standard of care hepatic artery embolization, during hepatic artery embolization, and at 4, 12, and 24 weeks post hepatic artery embolization.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorMelissa McGettigan
