DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

Abbreviated Magnetic Resonance Imaging and Biomarker-Based Detection of Early Liver Cancer

Principal Investigator: MARKS, ROBERT
Institution Receiving Award: HENRY M. JACKSON FOUNDATION
Program: PRCRP
Proposal Number: CA170674
Award Number: W81XWH-18-2-0024
Funding Mechanism: Translational Team Science Award
Partnering Awards: CA170674P1, CA170674P2
Award Amount: $297,340.00


PUBLIC ABSTRACT

Hepatocellular carcinoma (HCC) is the second leading cause of cancer-related death worldwide and is the fastest growing cause of cancer death in the United States. The mortality associated with this cancer is particularly high in U.S. military Veterans and beneficiaries, as these groups have increased risk factors that lead to liver cancer, such as high alcohol consumption, exposure to hepatitis B and C, and obesity. Current national guidelines recommend screening of all patients at risk for HCC with a lab draw and an ultrasound examination every 6 months. However, many studies have shown that ultrasound’s ability to detect cancer reliably, especially small tumors, is poor. As a result, ultrasound may detect the cancer only when it has grown to a large size and is no longer curable.

To detect cancer when it is small and potentially curable, many centers in the United States perform contrast-enhanced magnetic resonance imaging (MRI) for HCC screening. Although MRI is able to find small tumors, it is much more expensive than ultrasound. One of the major costs of MRI is the time it takes for each examination on the MRI table. The average liver MRI takes 30-45 minutes.

To lower the costs of MRI, we developed a new, abbreviated MRI (AMRI) method that takes approximately 10 minutes to complete. Our novel method requires only two sets of images, considerably less than the nine sets of images in a standard contrast-enhanced liver MRI. Based on preliminary studies we conducted to prepare this application, the AMRI method has at least 20% higher sensitivity for detecting liver cancer than ultrasound. In other words, AMRI is 20% more likely to detect cancer in patients with cancer, potentially allowing these patients to be cured. The Naval Medical Center San Diego (NMCSD) and the University of California, San Diego (UCSD) have used the AMRI method for clinical care, and preliminary studies have shown that it is cost-effective compared to ultrasound when used for HCC screening.

We propose to study the AMRI method against ultrasound for detecting HCC in a head-to-head comparison. The two methods will be done on the same day on the same patients at two different centers, NMCSD and UCSD. In addition, we will look at different blood tests that may help detect small HCC tumors and see how they perform in combination with AMRI and US.

This study will help patients with chronic liver disease, including patients with cirrhosis and chronic hepatitis B (cHBV) who are at risk for HCC, by showing that AMRI can detect small liver cancers more reliably than ultrasound and can be performed at only slightly higher cost. In addition, we will show that the information from blood tests may improve the ability of AMRI and ultrasound to detect small cancers. In order to achieve a patient-related outcome, this initial study will take 3 years to complete. If this study shows that AMRI is more accurate in detecting HCC than ultrasound, then a larger, multi-center, randomized control study will be needed to more fully understand the benefits of AMRI, which may possibly take another 4 to 5 years.

We anticipate that the successful completion of our study and of the larger study to follow will lead to widespread use of AMRI in combination with blood tests in military and civilian medical centers throughout the United States. This will allow liver cancer to be diagnosed earlier than is currently possible, potentially saving or prolonging the lives of thousands of Americans each year, including U.S. military, beneficiaries, and Veterans, that otherwise will die of this rapidly growing cause of cause death.