Contrast-Enhanced Ultrasound + Radioembolization for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen by John Eisenbrey, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Thomas Jefferson University

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

John Eisenbrey, PhD

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria

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.

Inclusion Criteria

Have signed informed consent to participate in the study

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

Be medically stable

Exclusion Criteria

I have a known heart shunt.

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

I have a history of bleeding disorders.

Treatment Details

Interventions

• Dynamic Contrast-Enhanced Ultrasound Imaging (Procedure)
• Perflutren Protein-Type A Microspheres (Ultrasound Contrast Agent)
• Yttrium-90 Microsphere Radioembolization (Procedure)

Trial Overview 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.

Participant Groups

Group I: Group I (perflutren protein-type A microspheres, CEUS) Experimental Treatment 3 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 Control 1 Intervention

Patients undergo standard of care yttrium Y-90 radioembolization.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Dr. Eugene Kennedy

Thomas Jefferson University

Chief Medical Officer since 2020

MD

Dr. Joseph G. Cacchione

Thomas Jefferson University

Chief Executive Officer since 2022

MD, MBA

Sidney Kimmel Cancer Center at Thomas Jefferson University

Lead Sponsor

Trials

164

Recruited

10,900+

Dr. Andrew Chapman

Sidney Kimmel Cancer Center at Thomas Jefferson University

Chief Executive Officer since 2022

Bachelor's degree from the University of Pennsylvania; D.O. from the University of Health Sciences College of Osteopathic Medicine in Kansas City, Missouri

Dr. Baligh R. Yehia

Sidney Kimmel Cancer Center at Thomas Jefferson University

Chief Medical Officer

MD, institution not specified

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School