Trial Information

The Incidence of Change in BCLC Stage by add-on Primovist-enhanced MRI During Initial Staging Work-up in HCC Patients Who Can be Candidates for Curative Treatment by Liver Dynamic CT: A Prospective Multicenter Study

Hepatocellular carcinoma (HCC) is one of the leading causes of cancer related death
worldwide, and its incidence continues to rise even in the Europe and the United States.
Recent advancements in early diagnosis and treatment modalities have significantly improved
survival in HCC patients, but, only a small portion of them can receive curative treatments.
Treatment decision making in HCC is guided by tumor stage, which can be also affected by
tumor status at presentation.Thus, intrahepatic tumor status can be pivotal for treatment
decision making and for determining prognosis in HCC patients, especially in possible
candidates for curative treatment.

The current AASLD guideline recommends that HCC patients with typical HCC ≥1 cm by liver
dynamic computed tomography (CT) do not require further investigation to confirm the
presence of HCC, and that appropriate treatment can be initiated based on tumor stage.
However, other intrahepatic HCC lesion which is not detected by liver dynamic CT can be
additionally detected only by Primovist-enhanced MRI.Although few studies have evaluated the
usefulness of Primovist-enhanced MRI in HCC patients,most of these studies have been limited
by the lack of an evaluation of shift in HCC stage and by the inclusion of patients with
suspicious intrahepatic HCC lesions that had been already detected by liver dynamic CT.
Furthermore, given the poor prognosis of HCC patients with recurrence after curative
treatments such as liver transplantation, surgical resection, or radiofrequency ablation
(RFA),accurate staging workup is essential for intrahepatic HCC, especially in patients with
a very early or early Barcelona Clinic Liver Cancer (BCLC) staged HCC. To date, however, no
evidence based recommendations have been made regarding the benefit of add-on examination of
Primovist-enhanced MRI during initial staging workups in HCC patients who are candidates for
curative treatment after diagnosis by liver dynamic CT.

In this prospective multicenter study, therefore, we will assess the usefulness of
Primovist-enhanced MRI during the initial staging workups of HCC patients with very early or
early stage disease, but with no suspicious intrahepatic HCC lesions by liver dynamic CT. We
will examine whether Primovist-enhanced MRI could provide additional information on BCLC
stage, by directly comparing to liver dynamic CT in these patients. Furthermore, we assess
whether add-on Primovist-enhanced MRI after a diagnosis of HCC by liver dynamic CT could aid
treatment decision making in these patients.