Multicenter study of gadopentetate dimeglumine as an MR contrast agent: evaluation in patients with spinal tumors.

Abstract

In an open-label, multicenter study, the efficacy and safety of gadopentetate dimeglumine (0.1 mmol/kg) administered IV as an MR imaging contrast agent were evaluated in 113 patients with symptoms of spinal tumors. The examinations were performed with a variety of imagers at different field strengths. Scans with short and long TRs were obtained in all patients before and after IV administration of the contrast medium. Contrast enhancement was seen in 77% of patients. No enhancement was seen in 23%, but this absence was useful diagnostic information in all cases. In 66% of the cases, additional information regarding location, size, configuration, and/or characterization of the lesion was obtained from postcontrast scans. The investigators made a change from referral diagnosis to postinjection diagnosis in 30% of the cases. Postinjection images provided additional information in 96% (43/45) of intradural extramedullary and intramedullary tumors; it also provided additional information in 20 (53%) of 38 cases of extradural tumor. Gadopentetate dimeglumine demonstrated a high level of safety and tolerance, as evidenced by the lack of clinically significant trends toward abnormal changes from baseline evaluations for physical and neurologic examinations, vital signs, and hematologic and blood chemistry parameters and by the low prevalence and mild nature of adverse reactions. Gadopentetate dimeglumine was found to be efficacious in the evaluation of suspected spinal tumors. High levels of safety and tolerance were demonstrated.