This phase II trial studies how well perflutren protein-type A microspheres and contrast-enhanced ultrasound work in improving response to radioembolization therapy in patients with liver cancer. Ultrasound contrast agents, such as perflutren protein-type A microspheres, use gas microbubbles to improve image quality. Using contrast-enhanced ultrasound imaging will “pop” these microbubbles and cause tumors to become more sensitive to radiation therapies.
Additional locations may be listed on ClinicalTrials.gov for NCT03199274.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Characterize the ability of localized ultrasound contrast agent destruction to improve hepatocellular carcinoma (HCC) response to yttrium Y-90 (Y90) radioembolization.
SECONDARY OBJECTIVE:
I. Determine if contrast-enhanced ultrasound estimated tumor perfusion can reliably predict HCC response to radioembolization 1-14 days post treatment.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive perflutren protein-type A microspheres intravenously (IV) over 10 minutes and undergo contrast-enhanced ultrasound (CEUS) over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.
GROUP II: Patients undergo standard of care yttrium Y-90 radioembolization.
After completion of study treatment, patients are followed up at 1 month and at 3-4 months.
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorJohn Eisenbrey
