The Laboratory for Advanced Medicine is sponsoring a clinical trial designed to evaluate the performance of the IvyGene Dx Liver Cancer Test alone, ultrasound alone and the combination of both the IvyGene Dx Liver Cancer Test and ultrasound for the detection of HCC within a population that is at high risk for HCC due to liver cirrhosis.
Subjects at high risk for developing liver cancer due to liver cirrhosis and who are eligible for liver cancer screening as determined by the patient’s physician will be invited to participate. Participation will consist of providing blood samples for testing with the IvyGeneTM Dx Liver Cancer Test and other blood analytes, undergoing abdominal ultrasound, and multiphasic MRI once upon entering the study.
The anticipated study duration for most subjects will be approximately 1 month to complete one round of HCC screening by using the IvyGene Dx Liver Cancer Test and ultrasound, and if needed, diagnostic imaging. Subjects that receive an indeterminant (LI-RADS score of 3) indication by diagnostic imaging will be recommended for a second round of HCC screening and diagnostic imaging in 6 months. Therefore, the anticipated study duration for these subjects that are recommended for a second round of HCC screening will be approximately 6 months.