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

Thomas Jefferson University

Status and phase: Active, not recruiting; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Perflutren Protein-Type A Microspheres; Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging; Procedure: Yttrium-90 Microsphere Radioembolization

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03199274

5R01CA238241 (U.S. NIH Grant/Contract)

17F.222

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Group I (perflutren protein-type A microspheres, CEUS)

Experimental group

Description:

Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.

Treatment:

Procedure: Yttrium-90 Microsphere Radioembolization

Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging

Drug: Perflutren Protein-Type A Microspheres

Group II (standard of care)

Active Comparator group

Description:

Patients undergo standard of care yttrium Y-90 radioembolization.

Treatment:

Procedure: Yttrium-90 Microsphere Radioembolization