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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lesion Detection in Cirrhotic Patients With Contrast Enhanced Ultrasound and the Accuracy of Contrast Enhanced Ultrasound Li-RADS for Hepatocellular Carcinoma Diagnosis

Conditions
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Cirrhosis

Intervention / Treatment
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* Procedure: Contrast-Enhanced Ultrasound
* Drug: Sulfur Hexafluoride Lipid Microspheres
* Procedure: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening (US, CEUS, Lumason)<br>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<br>* Undergo CEUS<br>* Other names: CEUS;Drug: Sulfur Hexafluoride Lipid Microspheres<br>* Given IV<br>* Other names: Sulfur Hexafluoride Lipid-type A Microspheres;Procedure: Ultrasound<br>* Undergo non-contrast US<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of contrast enhanced ultrasound (CEUS) with contrast agent sulfur hexafluoride lipid-type A microspheres and B-mode non-contrast enhanced ultrasound | 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. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of CEUS and contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads) | 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. | Up to 3 years |