Summary
Primary objectives: The primary objective of this study is to compare the performance (sensitivity and specificity) of ultrasound alone to the combination of both ultrasound and the IvyGene® Dx Liver Cancer Test for the detection of hepatocellular carcinoma within a high-risk population. The primary method to confirm or rule out the presence of hepatocellular carcinoma will be diagnostic imaging by using multiphasic MRI. Secondary objectives: The secondary objectives of this study are:1) To compare the performance (sensitivity and specificity) of ultrasound alone to the IvyGene® Dx Liver Cancer Test alone for the detection of hepatocellular carcinoma.2) To compare the performance (sensitivity and specificity) of ultrasound alone to the combination of both ultrasound and the IvyGene® Dx Liver Cancer Test for the detection of hepatocellular carcinoma lesions that are ≤ 2cm in diameter.3) To compare the performance (sensitivity and specificity) of ultrasound alone to the IvyGene® Dx Liver Cancer Test alone for the detection of hepatocellular carcinoma lesions that are ≤ 2cm in diameter.
Inclusion Criteria
- Subject is age 21 to 84 (inclusive)
- Subject is able to read, comprehend and sign the Informed Consent Document
- Subject is willing and able to undergo liver cancer surveillance by ultrasound and the multi-analyte blood Test
- Subject is able and willing to undergo diagnostic imaging by multiphasic MRI with contrast according to the Study Protocol
Study Location(s)
Cedars-Sinai Cancer at SOCC
More about this Clinical Trial
Full Title
LAM-2018-01: Prospective Clinical Trial to Detect Liver Cancer through Quantification of cfDNA Methylation in Blood Samples