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Contrast-Enhanced Ultrasound + Radioembolization for Liver Cancer

Phase 2

Waitlist Available

Led By John Eisenbrey, PhD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Patients with known cardiac shunts

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses ultrasound contrast agents to improve response to radioembolization therapy in patients with liver cancer.

Who is the study for?

This trial is for stable adults with untreated liver cancer (HCC) masses under 6 cm, visible on ultrasound. They must consent to the study and women of childbearing age need a negative pregnancy test before each exam. It's not for critically ill patients, those with high bilirubin levels or heart failure, pregnant/nursing women, or anyone allergic to perflutren.

What is being tested?

The trial tests if using Perflutren Protein-Type A Microspheres with contrast-enhanced ultrasound can improve the effectiveness of Yttrium-90 radioembolization therapy in treating liver cancer by making tumors more sensitive to radiation.

What are the potential side effects?

Potential side effects may include allergic reactions to perflutren microspheres such as shortness of breath or skin rashes. The procedure could also cause discomfort at the injection site and has risks associated with exposure to radiation from the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a specific liver cancer treatment for a tumor smaller than 6 cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known heart shunt.

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I have severe emphysema, pulmonary vasculitis, or a history of pulmonary embolism.

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I have a history of bleeding disorders.

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I am currently on life support or in a critical care unit.

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I do not have unstable heart rhythm problems like frequent fast heartbeats.

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I do not have severe, uncontrolled heart failure.

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I have worsening chest pain due to heart artery blockage.

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I am not pregnant or nursing.

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I have had a recent brain bleed.

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I have respiratory distress syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment response to yttrium Y-90 radioembolization

Tumor perfusion measured by contrast-enhanced ultrasound between ultrasound-triggered microbubble destruction pulses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (perflutren protein-type A microspheres, CEUS)Experimental Treatment3 Interventions

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 II: Group II (standard of care)Active Control1 Intervention

Patients undergo standard of care yttrium Y-90 radioembolization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dynamic Contrast-Enhanced Ultrasound Imaging

2018

Completed Phase 1

~630

0 / 11Eligibility criteria met