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

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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

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

Trial contacts and locations

1

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Central trial contact

John Eisenbrey, PhD

Data sourced from clinicaltrials.gov

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