A Prospective Intra-individual Cohort Study to Compare Gadoxetic Acid (Primovist®)-Enhanced Magnetic Resonance Image and Ultrasonography for the Surveillance of Early Stage Hepatocellular Carcinoma in Patients at High-risk
Hepatocellular carcinoma (HCC) is currently the third leading cause of cancer-related deaths
worldwide. Cirrhosis, particularly when related to viral hepatitis, is the most notable risk
factor for HCC and is found in nearly 80-90% of cases.
The stage of disease at the time of diagnosis largely determines the effectiveness of
treatment. The treatment of advanced HCC continues to be primarily palliative, with curative
options only available for early HCC. Unfortunately, less than 30% of patients are
diagnosed early enough to meet criteria for resection, transplantation, or local ablation.
Surveillance strives to detect HCC at an early stage when it is amenable to curative therapy
to reduce mortality. Current practice guidelines recommend surveillance of cirrhotic
patients with ultrasonography (USG) every 6 months. However, USG has been reported to have a
sensitivity of between 65% and 80% when used as a screening test. However, with the
advancement of cirrhosis, the sensitivity of USG decreases, while the risk for HCC
Gadoxetic acid (Primovist®)-enhanced magnetic resonance imaging (MRI) of the liver has been
demonstrated to be of clinical value for local staging before HCC surgery and for the
assessment of patients with inconclusive conventional imaging findings. The detection
sensitivity of Primovist-MRI has been known to be as high as 90-95%, which is significantly
higher than USG or multiphase computer tomography (CT) scan. MRI does not have radiation
exposure, which is a meaningful merit to be used as a surveillance test. However, MRI has
never been considered for surveillance or screening of HCC.
Thus, the hypothesis to be proved by this study is as follows; Primovist-MRI should show
significantly higher sensitivity compared to USG for the detection of early stage HCC when
both of these imaging modalities are used with the interval of 6 months in patients with
cirrhosis at high risk of developing HCC. The investigators will also analyze whether the
specificity of Primovist-MRI are not compromised by its high sensitivity.
Observational Model: Cohort, Time Perspective: Prospective
The detection sensitivity of early stage HCC
The number of definite HCC nodules of early stage detected by a given modality divided by the total number of definite HCC nodules of early stage detected by any of 2 modalities plus interval cancers Early stage (stage A or 0) HCC is defined by the Barcelona Clinic Liver Cancer staging system (BCLC): A single HCC <5 cm or <=3 lesions each <3 cm in diameter, without gross vascular invasion or extrahepatic metastasis.
during the 1.5-year study period (from the date of first screening to 6 months following the last screening)
Young-Suk Lim, MD, PhD
Asan Medical Center
South Korea: Institutional Review Board