Gadodiamide injection as a contrast medium for MRI of the central nervous system: a comparison with gadolinium-DOTA.

The tolerance and diagnostic efficacy of a new nonionic, intravenous MRI contrast medium, gadodiamide injection (Omniscan) are reported and compared with those of gadolinium-DOTA after completion of a double-blind, randomized, parallel study in 60 patients using a dose of 0.1 mmol/kg. Two patients were excluded from the statistical analysis after trial entrance since no contrast medium was injected. The indications for the MRI examination were known or suspected CNS lesions. Vital signs, chemical and haematological parameters were monitored. No significant abnormalities were observed, confirming the excellent tolerance of both contrast media. The usefulness of gadolinium-containing contrast media was again documented, since in 8.6% (5/58) of the patients the lesion(s) could be seen only after injection. Contrast enhancement was seen in 87.8% (43/49) of the patients with abnormal findings, and provided additional diagnostic information in 24.5% (12/49). Lack of contrast enhancement in 12.2% (6/49) of patients with abnormal findings was a significant negative finding.

RCT Entities:   Population Interventions Outcomes