Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization
NCT ID: NCT03300401
Last Updated: 2019-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-11-07
2020-11-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (CEUS)
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.
Perflutren Lipid Microspheres
Receive intravenous injection just prior to ultrasound
Sulfur Hexafluoride Lipid Microspheres
Receive intravenous injection just prior to ultrasound
Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo Contrast-Enhanced Ultrasound Imaging
Positron Emission Tomography
Undergo PET/CT
Computed Tomography
Undergo CT scan
Yttrium-90 (90Y)
Given IV
Interventions
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Perflutren Lipid Microspheres
Receive intravenous injection just prior to ultrasound
Sulfur Hexafluoride Lipid Microspheres
Receive intravenous injection just prior to ultrasound
Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo Contrast-Enhanced Ultrasound Imaging
Positron Emission Tomography
Undergo PET/CT
Computed Tomography
Undergo CT scan
Yttrium-90 (90Y)
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Harshawn Malhi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2017-01422
Identifier Type: REGISTRY
Identifier Source: secondary_id
3L-17-3
Identifier Type: OTHER
Identifier Source: secondary_id
3L-17-3
Identifier Type: -
Identifier Source: org_study_id
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