How frequently does hepatocellular carcinoma develop in at-risk patients with a negative liver MRI examination with intravenous Gadobenate dimeglumine?

Objective: To determine the rate of development of clinically significant liver nodules (LR-4, LR-5, LR-M) after a negative MRI in an HCC screening population. Methods: This retrospective study included patients at risk of developing HCC requiring imaging surveillance who had undergone multiphase Gadobenate dimeglumine-enhanced MRI that was negative and had follow up LI-RADS compliant multiphase CTs or MRIs for at least 12 months or positive follow-up within 12 months. Follow-up examinations were classified as negative (no nodules or only LR-1 nodules) or positive (nodule other than LR-1). Time-to-first positive examination, types of nodules, and cumulative incidence of nodule development were recorded. Results: 204 patients (mean age 58.9 ± 10.2 years, 128 women), including 172 with cirrhosis, were included. Based CT/MRI follow-up (median 35 months, range 12–80 months), the overall cumulative incidence of developing a nodule was 10.5%. Cumulative incidence of nodule development was: 0.5% at 6–9 months and 2.1% at 12 ± 3 months, including one LR-4 nodule, one LR-M nodule, and two LR-3 nodules. The cumulative incidence of clinically significant nodule development was 1.1% at 9–15 months. 70% (143/204) of patients also underwent at least one US follow-up, and no patient developed a positive US examination following index negative MRI. Conclusion: Clinically significant liver nodules develop in 1.1% of at-risk patients in the first year following negative MRI. While ongoing surveillance is necessary for at-risk patients, our study suggests than longer surveillance intervals after a negative MRI may be reasonable and that further research is needed to explore this possibility.