Lesion Detection in Cirrhotic Patients With Contrast Enhanced Ultrasound and the Accuracy of Contrast Enhanced Ultrasound Li-RADS for Hepatocellular Carcinoma (HCC) Diagnosis
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 12, 2018 |
| End Date: | September 30, 2022 |
| Contact: | Ott Le, MD |
| Email: | CR_Study_Registration@mdanderson.org |
| Phone: | 713-792-3673 |
The goal of this clinical research study is to find out if ultrasound scans using a contrast
agent called Lumason (sulfur hexafluoride lipid-type A microspheres) can help doctors more
easily find liver lesions (including hepatocellular carcinoma [HCC]), compared to ultrasounds
without contrast agent. Contrast agents are drugs that are injected into a vein in order to
help certain organs and tissues show up more clearly on scans.
Researchers will also compare the effectiveness of liver ultrasounds using Lumason versus
standard MRI imaging, in patients with cirrhosis of the liver.
This is an investigational study. Ultrasound and MRI scans on this study are performed using
FDA-approved and commercially available methods.
Up to 150 patients will be enrolled on this research study. All will take part at MD
Anderson.
agent called Lumason (sulfur hexafluoride lipid-type A microspheres) can help doctors more
easily find liver lesions (including hepatocellular carcinoma [HCC]), compared to ultrasounds
without contrast agent. Contrast agents are drugs that are injected into a vein in order to
help certain organs and tissues show up more clearly on scans.
Researchers will also compare the effectiveness of liver ultrasounds using Lumason versus
standard MRI imaging, in patients with cirrhosis of the liver.
This is an investigational study. Ultrasound and MRI scans on this study are performed using
FDA-approved and commercially available methods.
Up to 150 patients will be enrolled on this research study. All will take part at MD
Anderson.
If you are found to be eligible to take part in this study, within 2 weeks after your routine
care MRI scan, you will have a standard ultrasound performed on your abdomen without using a
contrast agent. This involves placing some ultrasound gel directly on the skin and moving a
transducer (probe) over the surface of your abdomen, as you lie (usually face-up) on an
examination table.
You will then have another ultrasound performed in the same way. However, before this
ultrasound, the contrast agent Lumason will be injected into your vein in your arm. The 2
ultrasounds will take about an hour to complete.
As part of this study, some of the information from your medical record will also be
collected as needed.
The information from your medical record and the images from the 3 scans (the routine MRI and
the 2 ultrasounds) will be stored in a research database indefinitely. Your data will be
given a code number. No identifying information will be directly linked to your data. Only
the researchers in charge of the database will have access to the code numbers and be able to
link the data to you. This is to allow medical data related to the data to be updated as
needed.
Length of Study:
Your participation on this study will be over after the 2 ultrasounds. Your primary care team
will follow up with you, according to standard care.
care MRI scan, you will have a standard ultrasound performed on your abdomen without using a
contrast agent. This involves placing some ultrasound gel directly on the skin and moving a
transducer (probe) over the surface of your abdomen, as you lie (usually face-up) on an
examination table.
You will then have another ultrasound performed in the same way. However, before this
ultrasound, the contrast agent Lumason will be injected into your vein in your arm. The 2
ultrasounds will take about an hour to complete.
As part of this study, some of the information from your medical record will also be
collected as needed.
The information from your medical record and the images from the 3 scans (the routine MRI and
the 2 ultrasounds) will be stored in a research database indefinitely. Your data will be
given a code number. No identifying information will be directly linked to your data. Only
the researchers in charge of the database will have access to the code numbers and be able to
link the data to you. This is to allow medical data related to the data to be updated as
needed.
Length of Study:
Your participation on this study will be over after the 2 ultrasounds. Your primary care team
will follow up with you, according to standard care.
Inclusion Criteria:
1. Able and willing to provide written informed consent
2. Age > 18 years of age
3. Diagnosis of cirrhosis based on one or more of the following: Histology, US, CT or MRI
showing cirrhosis, +/- lesions seen on CE-MRI
Exclusion Criteria:
1. History of hypersensitivity to sulfur hexafluoride lipid microsphere components or to
any of the inactive ingredients in Lumason
2. Pregnant patients-excluded by history
3. Pediatric patients, as pediatric cirrhosis is uncommon
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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