Contrast Enhanced Ultrasound With Lumason in Detecting Liver Cancer in Participants With Cirrhosis
NCT ID: NCT03407001
Last Updated: 2020-10-14
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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COMPLETED
EARLY_PHASE1
9 participants
INTERVENTIONAL
2018-01-12
2020-09-15
Brief Summary
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Detailed Description
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I. Determine the accuracy of contrast enhanced ultrasound (CEUS) utilizing contrast agent sulfur hexafluoride lipid-type A microspheres compared to B-mode non-contrast enhanced ultrasound for liver lesion detection, including hepatocellular carcinoma (HCC), in cirrhotic ultrasound (US) patients.
SECONDARY OBJECTIVES:
I. Determine the concordance of CEUS vs. contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads).
OUTLINE:
Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason intravenously (IV) and undergo contrast-enhanced ultrasound of the abdomen over 1 hour.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Screening (US, CEUS, Lumason)
Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason IV and undergo contrast-enhanced ultrasound of the abdomen over 1 hour in the absence of disease progression or unacceptable toxicity.
Contrast-Enhanced Ultrasound
Undergo CEUS
Sulfur Hexafluoride Lipid Microspheres
Given IV
Ultrasound
Undergo non-contrast US
Interventions
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Contrast-Enhanced Ultrasound
Undergo CEUS
Sulfur Hexafluoride Lipid Microspheres
Given IV
Ultrasound
Undergo non-contrast US
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of cirrhosis based on one or more of the following: histology, US, computed tomography (CT) or MRI showing cirrhosis, +/- lesions seen on CE-MRI
Exclusion Criteria
* Pregnant patients-excluded by history
* Pediatric patients, as pediatric cirrhosis is uncommon
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ott Le
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-00895
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0691
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0691
Identifier Type: -
Identifier Source: org_study_id
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