Early Phase II Trial of Gd-BOPTA (E7155) for the MR Imaging of Liver Tumors

A clinical early phase II trial of Gd-BOPTA (E7155) was performed to assess its safety and usefulness for the detection of the hepatic lesions. Seventy-nine patients were assigned to three groups ; a low dose group (0.025 mmol/kg), medium dose group (0.05 mmol/kg) and high dose group (0.1 mmol/kg). In terms of safety, Gd-BOPTA was assessed as "safe" in 76 patients and "somewhat questionable" in three patients including one with nausea and two with obvious changes in laboratory findings. No severe adverse reaction was experienced. In terms of the usefulness of dynamic study, the percentage of more than "useful" in the high dose group, medium dose group and low dose group were 100%, 100% and 76.9%. respectively. The result of "usefulness" of early and delayed post-contrast images showed more than "useful" in over 60% of cases. These results indicated that both dynamic and post-contrast early and delayed images were useful for the evaluation of liver tumors, suggesting that this contrast agent would have characteristics of both extracellular and liver-specific contrast agents.