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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Perflutren Lipid Microspheres
* Drug: Sulfur Hexafluoride Lipid Microspheres
* Device: Dynamic Contrast-Enhanced Ultrasound Imaging
* Device: Positron Emission Tomography
* Device: Computed Tomography
* Biological: Yttrium-90 (90Y)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (CEUS)<br>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 PET/CT after standard of care 90Y radioembolization at baseline. | Drug: Perflutren Lipid Microspheres<br>* Receive intravenous injection just prior to ultrasound<br>* Other names: Definity;Drug: Sulfur Hexafluoride Lipid Microspheres<br>* Receive intravenous injection just prior to ultrasound<br>* Other names: Lumason;Device: Dynamic Contrast-Enhanced Ultrasound Imaging<br>* Undergo Contrast-Enhanced Ultrasound Imaging<br>* Other names: Contrast-Enhanced Ultrasound Imaging;Device: Positron Emission Tomography<br>* Undergo PET/CT<br>Device: Computed Tomography<br>* Undergo CT scan<br>* Other names: Computerized Axial Tomography;Biological: Yttrium-90 (90Y)<br>* Given IV<br>* Other names: 90Y microsphere;|

What is the study measuring?
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Primary Outcome Measures

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