Hepatocellular carcinoma (HCC) often has a poor prognosis after curative treatment due to frequent recurrence. Post-surgery, 60-70% of HCC patients experience recurrence, rising to 80% after ablation therapy. This is partly because underlying cirrhosis or chronic liver disease remains, increasing the risk of secondary HCC. The risk of recurrence varies over time, with a high risk in the first two years due to micro-metastasis. Later recurrences are usually new primary cancers (de novo HCC). Therefore, regular imaging tests, such as computed tomography (CT) or magnetic resonance imaging (MRI) every three months in the first two years, are necessary for early detection, but guidelines for post-two-year screenings are unclear.
Currently, for patients recurrence-free for two years, contrast-enhanced liver CT or MRI is performed every 3-6 months as a secondary screening test. However, repeated use of CT raises concerns about radiation exposure and iodine-based contrast agents can lead to side effects and kidney issues. MRI with hepatocyte-specific agents like gadoxetic acid (Primovist) is effective but costly and time-consuming, with potential side effects from repeated gadolinium exposure. Therefore, there is a need for a validated secondary screening method that is both effective and reduces patient risk.
Abbreviated contrast-enhanced MRI, using only essential sequences, has shown promise in retrospective studies for detecting HCC. However, these studies have limitations, such as potential bias and lack of data on repeated screenings. There is limited research on secondary screening post-curative treatment for HCC. This study aims to prospectively evaluate the use of abbreviated contrast-enhanced MRI with Primovist as a secondary screening method for detecting secondary HCC in patients who have been recurrence-free for more than two years.
Patients with more than two years without recurrence after curative treatment (surgery or local ablation) for HCC
Patients with no history of systemic treatment, radiation therapy, or trans-arterial chemoembolization for HCC
Older than 20 years of age
Eastern Cooperative Oncology Group performance status of 0-2
Active or suspected cancer, or a history of malignancy where the risk of recurrence is equal or higher than 20% within 2 years.
Significant medical comorbidities in which survival is predicted to be less than 3 years
Estimated glomerular filtration rate < 30 mL/min/1.73m²
Child-Pugh class C
Single group
AMRI
Diagnostic testThe study subjects will receive intravenous injection of gadoxetic acid (0.025 mmol/kg, Primovist; Bayer, Berlin, Germany) in the waiting room and then proceed to the examination room for MRI testing 15-20 minutes later. The MRI examination will be conducted using a 3-Tesla MRI machine, and the MRI protocol consists of T2-weighted imaging,diffusion-weighted imaging (b value of 0, 50, and 500 s/mm2), and hepatobiliary phase imaging.
CT
Diagnostic testCT will be performed by obtaining dynamic phases (precontrast phase, arterial phase, portal venous phase, and delayed phase images). Subjects will receive intravenous injection of iodine contrast media. Scan coverage was from the basal lung to the iliac crest or pelvis.
Detection rate (DR) of patients with HCC
DR = True positive / True positive + False positive + True negative + False negative
False referral rate (FRR) of patients with HCC
FRR = False positive / True positive + False positive + True negative + False negative
DR of patients with early stage HCC
DR = True positive / True positive + False positive + True negative + False negative
FRR of patients with early stage HCC
FRR = False positive / True positive + False positive + True negative + False negative
DR of patients with very early stage HCC
DR = True positive / True positive + False positive + True negative + False negative
FRR of patients with very early stage HCC
FRR = False positive / True positive + False positive + True negative + False negative
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