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

M.D. Anderson Cancer Center

Status and phase: Completed; Early Phase 1

Conditions: Cirrhosis

Treatments: Drug: Sulfur Hexafluoride Lipid Microspheres; Procedure: Contrast-Enhanced Ultrasound; Procedure: Ultrasound

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03407001

P30CA016672 (U.S. NIH Grant/Contract)

2017-0691 (Other Identifier)

R01CA195524 (U.S. NIH Grant/Contract)

NCI-2018-00895 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Screening (US, CEUS, Lumason)

Experimental group

Description:

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.

Treatment:

Procedure: Ultrasound

Procedure: Contrast-Enhanced Ultrasound

Drug: Sulfur Hexafluoride Lipid Microspheres