Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT03407001


Primary Contact:

Principal Investigator
Ott Le
M.D. Anderson Cancer Center

Ott Le
Phone: 713-792-3673
Email: ott.le@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Ott Le
Phone: 713-792-3673

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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