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

The Role of Quantitative Contrast-Enhanced Ultrasound in Yttrium-90 (90Y) Radioembolization of Hepatocellular Carcinoma

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03300401

Enrollment

Registered

2017-10-03

Start date

2017-11-07

Completion date

2020-11-07

Last updated

2019-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

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.

Detailed description

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.

Interventions

DRUGPerflutren Lipid Microspheres

Receive intravenous injection just prior to ultrasound

DRUGSulfur Hexafluoride Lipid Microspheres

Receive intravenous injection just prior to ultrasound

DEVICEDynamic Contrast-Enhanced Ultrasound Imaging

Undergo Contrast-Enhanced Ultrasound Imaging

DEVICEPositron Emission Tomography

Undergo PET/CT

DEVICEComputed Tomography

Undergo CT scan

BIOLOGICALYttrium-90 (90Y)

Given IV

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Local tumor response to therapy	Up to 24 weeks	Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026