Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization

University of Southern California

Overview

This pilot clinical trial studies how well contrast-enhanced ultrasound in diagnosing patients with liver cancer who are undergoing Yttrium-90 radioembolization. Contrast-enhanced ultrasound may provide detailed imaging of the tumor arteries after the injection of a contrast-agent consisting of microbubbles, and may predict how much Yttrium-90 will deposit in the tumor.

PRIMARY OBJECTIVES: I. Investigate the relationship between hepatocellular carcinoma (HCC) tumor perfusion on pre-procedural contrast-enhanced ultrasound (CEUS) time intensity curve (TIC) and post-procedural Yttrium-90 (90Y) microsphere distribution after 90Y radioembolization (RE). SECONDARY OBJECTIVES: I. Study the potential of serial CEUS TIC examinations as a marker of tumor treatment response as assessed at 20 - 24 week computed tomography (CT) follow-up. OUTLINE: Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo positron emission tomography/computed tomography (PET/CT) after standard of care 90Y radioembolization at baseline.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Hepatocellular Carcinoma

Interventions

Perflutren Lipid MicrospheresDRUG

Receive intravenous injection just prior to ultrasound

Sulfur Hexafluoride Lipid MicrospheresDRUG

Receive intravenous injection just prior to ultrasound

Dynamic Contrast-Enhanced Ultrasound ImagingDEVICE

Undergo Contrast-Enhanced Ultrasound Imaging

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients scheduled for 90Y radioembolization for HCC as part of their standard of care Exclusion Criteria: * Patients who have already received tumor treatment (either systemic or loco-regional such as previous Y90RE, microwave or radiofrequency \[RF\] ablation or transarterial chemoembolization \[TACE\]) * Pregnant or nursing * Known cardiac shunt * Known pulmonary hypertension * History of hypersensitivity to Definity (perflutren lipid microsphere) or Lumason * History of hypersensitivity to iodinated contrast agent * Cannot consent for himself or herself

Locations (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Local tumor response to therapy

Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.

Time frame: Up to 24 weeks

Data from ClinicalTrials.gov

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