CEUS EVALUATION OF FOCAL LIVER LESIONS IN PATIENTS WITH CIRRHOSIS
Research type
Research Study
Full title
Contrast-enhanced ultrasound evaluation of focal liver lesions in patients with cirrhosis or other risk factors for developing HCC.
IRAS ID
232211
Contact name
Paul Sidhu
Contact email
Sponsor organisation
Thomas Jefferson University Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 11 days
Research summary
This study aims to determine whether another type of imaging test with ultrasound imaging and a contrast agent, that does not involve radiation, can detect tumors in livers. If successful, it is possible people can have this ultrasound imaging exam rather than MRI (magnetic resonance imaging) or CT (computed tomography). The purpose of this study is to compare the results of ultrasound imaging with contrast (CEUS) with that of the ultrasound without contrast, MRI or CT or biopsy/surgical excision.
The ultrasound contrast agent being used in this study is Lumason, which is made of tiny gas bubbles about the same size as red blood cells that reflect ultrasound (sound waves). The microbubbles stay in areas of blood vessels show where there is blood flow. Lumason is FDA approved and licensed in Europe and the USA for ultrasound of the liver.
640 patients will participate internationally across four countries, in 9 hospitals. All will have a mass in the liver and long term liver disease. Each participant will be in the study for about 1 hour. The entire study will take about 4 years to complete.
For CEUS, a cannula (small plastic tube) will be placed in a vein and the participant will be asked to lay on an examination table. The participant will receive an injection (approximately 1 teaspoon) of Lumason through the cannula, followed by an injection of saline (salt water). An ultrasound probe will be moved across the abdomen using a gel to obtain the ultrasound images.The CEUS findings will be compared to the other recent ultrasound results, MRI or CT or biopsy/surgical excision results.
Participation in this study is entirely voluntary. The alternative to being in the study is to only have the standard of care MRI or CT Scan or biopsy/surgical excision.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/2180
Date of REC Opinion
5 Feb 2019
REC opinion
Favourable Opinion