Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer

• Status: Recruiting
• Trial end date: 2023-12-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Be scheduled for sub-lobar radioembolization therapy of a previously untreated HCC mass < 6 cm visible on grayscale ultrasound

• Be medically stable

• If a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam

• Have signed informed consent to participate in the study

Exclusion Criteria:

• Females who are pregnant or nursing

• Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:

• Patients on life support or in a critical care unit

• Patients with unstable occlusive disease (e.g., crescendo angina)

• Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia

• Patients with uncontrolled congestive heart failure (New York heart Association [NYHA] class IV)

• Patients with recent cerebral hemorrhage

• Patients with known sensitivities to albumin, blood, or blood products

• Patients with known hypersensitivity to perflutren

• Patients with known cardiac shunts

• Patients with known congenital heart defects

• Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary embolism

• Patients with respiratory distress syndrome

• Patients with a history of bleeding disorders

• Patients with bilirubin levels > 2 mg/dL