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Contrast Enhanced Ultrasound With Lumason in Detecting Liver Cancer in Participants With Cirrhosis

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ClinicalTrials.gov Identifier: NCT03407001
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This early phase I trial studies how well contrast enhanced ultrasound with sulfur hexafluoride lipid microspheres (Lumason) works in detecting liver cancer in participants with cirrhosis. Contrast enhanced-ultrasounds use contrast agents, such as Lumason, that are injected into a vein in order to help certain organs and tissues show up more clearly on scans. Contrast enhanced ultrasound with Lumason may help doctors more easily find liver cancer compared to ultrasounds without contrast agent.

Condition or disease Intervention/treatment Phase
Cirrhosis Procedure: Contrast-Enhanced Ultrasound Drug: Sulfur Hexafluoride Lipid Microspheres Procedure: Ultrasound Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Lesion Detection in Cirrhotic Patients With Contrast Enhanced Ultrasound and the Accuracy of Contrast Enhanced Ultrasound Li-RADS for Hepatocellular Carcinoma Diagnosis
Actual Study Start Date : January 12, 2018
Actual Primary Completion Date : September 15, 2020
Actual Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Procedure: Contrast-Enhanced Ultrasound
Undergo CEUS
Other Name: CEUS

Drug: Sulfur Hexafluoride Lipid Microspheres
Given IV
Other Names:
  • Lumason
  • SF6 Lipid Microspheres
  • Sulfur Hexafluoride Lipid-type A Microspheres

Procedure: Ultrasound
Undergo non-contrast US


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of contrast enhanced ultrasound (CEUS) with contrast agent sulfur hexafluoride lipid-type A microspheres and B-mode non-contrast enhanced ultrasound [ Time Frame: Up to 3 years ]
    The study will estimate the sensitivity of ultrasound (US) and CEUS in patients with detectable lesions on magnetic resonance imaging (MRI). The analysis will be conducted at the patient level with a binary outcome of 0 if the patient has no detectable lesions and 1 if the patient has one or more detectable lesions. The study will use McNemar's test to compare US vs. CEUS in patients with any detectable lesions on MRI. The test assesses whether the two tests have equivalent marginal probabilities (i.e. probability of detecting at least one lesion with US and CEUS is equivalent). McNemar's test statistic depends only on patients where US and CEUS disagree.


Secondary Outcome Measures :
  1. Assessment of CEUS and contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads) [ Time Frame: Up to 3 years ]
    The study will assess the concordance between CEUS Li-Rads and MRI Li-Rads scoring results for each lesion using a multinomial logit random effects model. The study will summarize the characteristics (the size, location, vascularity and enhancement pattern) of lesions detected by only one imaging modality, stratified by imaging type.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to provide written informed consent
  • 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:

  • History of hypersensitivity to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason
  • Pregnant patients-excluded by history
  • Pediatric patients, as pediatric cirrhosis is uncommon
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407001


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ott Le M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03407001    
Other Study ID Numbers: 2017-0691
NCI-2018-00895 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0691 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
R01CA195524 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases