Evaluation of gadobenate dimeglumine in hepatocellular carcinoma: Results from phase II and phase III clinical trials in Japan

To evaluate the clinical efficacy of gadobenate dimeglumine (Gd-BOPTA)-enha nced magnetic resonance imaging for hepatocellular carcinoma (HCC), we revi ewed the results of clinical phase II and III trials in Japan. Gd-BOPTA was administered at a dose of 0.1 mmol/kg to 139 patients who were suspected t o have HCC. Dynamic phase images (breath-hold T1-weighted gradient echo [GR E)], spin-echo (SE) images obtained within 10 minutes of injection, and del ayed breath-hold GRE images obtained 40-120 minutes after injection were ev aluated, All post-contrast images were compared with T1- and Ta-weighted pr e-contrast images. The contrast efficacy for the dynamic study was classified as (+++) or (++) in 92.1% (128/139), in 43.1% (59/ 137) with SE within 10 minutes of inject ion, and in 43.2% (60/139) with breath-hold GRE at delayed phase, The incre ase in lesion-liver contrast-to-noise ratio was best at the arterial phase of dynamic breath-hold GRE. Liver signal-to-noise ratio showed a mean 52.3% increase in delayed phase, Additional information at delayed phase compare d with images acquired within 10 minutes of injection (including the dynami c study) was classified as (+++) or (++) in 28.1% (39/139), With regard to safety, the overall incidence of adverse reactions was 5.0% (7/141) of the patients who were suspected to have HCC, all of whom recovered within 12 ho urs without any sequelae, No clinically important changes were observed in the blood and urine laboratory tests. It was concluded that Gd-BOPTA was we ll tolerated and effective in both dynamic study and delayed static imaging for the diagnosis of HCC. (C) 1999 Wiley-Liss, Inc.