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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2023
  • participants needed
    104
  • sponsor
    Sidney Kimmel Cancer Center at Thomas Jefferson University
Updated on 12 November 2021
liver cancer
cancer
carcinoma
hepatocellular carcinoma
radioembolization

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.

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.

Details
Condition HEPATOCELLULAR CARCINOMA, Malignant Adenoma, Liver Cancer, Adenocarcinoma, cancer, hepatocellular, HEPATIC NEOPLASM, liver cell carcinoma, cancer, liver, liver cancers, Biliary Tract Cancer, cancer, hepatic
Treatment SPECT imaging, Yttrium-90 Microsphere Radioembolization, Perflutren Protein-Type A Microspheres, Dynamic Contrast-Enhanced Ultrasound Imaging
Clinical Study IdentifierNCT03199274
SponsorSidney Kimmel Cancer Center at Thomas Jefferson University
Last Modified on12 November 2021

Eligibility

Yes No Not Sure

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
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