Use of the magnetic resonance contrast agent gadodiamide in the central nervous system. Results of a multicenter trial.

ABSTRACT

To investigate the safety and efficacy of the low-osmolar, nonionic contrast agent, gadodiamide injection (Omniscan, Sanofi Winthrop Pharmaceuticals, New York, NY), for magnetic resonance imaging (MRI) of the head and spine, a multicenter study involving 439 patients was done at 15 centers as part of a Phase II/III clinical trial. Unenhanced MRI scans were obtained after which the patients were injected with 0.1 mmol/kg gadodiamide, and the MRI was repeated. The patients' vital signs were monitored, and laboratory studies were conducted. Neurologic status was examined before and after the study. The images were evaluated for contrast enhancement. No patient had any significant adverse event or serious change in clinical status. Abnormalities were found in 80% (351) of all patients studied, and it was found that, in 75% (266) of these, the postgadodiamide injection images were improved or facilitated visualization of lesions compared with preinjection images. The investigators believe that, based on the results of this study, gadodiamide injection is safe and effective for imaging the head and spine. They suggest that future studies further assess and compare the safety parameters of gadodiamide injection with those of other nonionic and ionic gadolinium ligands.