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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2025-01-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

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.

Group Type EXPERIMENTAL

Yttrium-90 Microsphere Radioembolization

Intervention Type PROCEDURE

Undergo standard of care Y-90 radioembolization

Perflutren Protein-Type A Microspheres

Intervention Type DRUG

Given IV.

Dynamic Contrast-Enhanced Ultrasound Imaging

Intervention Type PROCEDURE

Undergo CEUS

Group II (standard of care)

Patients undergo standard of care yttrium Y-90 radioembolization.

Group Type ACTIVE_COMPARATOR

Yttrium-90 Microsphere Radioembolization

Intervention Type PROCEDURE

Undergo standard of care Y-90 radioembolization

Interventions

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Yttrium-90 Microsphere Radioembolization

Undergo standard of care Y-90 radioembolization

Intervention Type PROCEDURE

Perflutren Protein-Type A Microspheres

Given IV.

Intervention Type DRUG

Dynamic Contrast-Enhanced Ultrasound Imaging

Undergo CEUS

Intervention Type PROCEDURE

Other Intervention Names

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Yttrium Y 90 Microsphere Therapy Yttrium-90 Radioembolization Optison

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No