SAFETY AND EFFICACY OF DOTAREM (GD-DOTA) VERSUS MAGNEVIST (GD-DTPA) IN MAGNETIC-RESONANCE-IMAGING OF THE CENTRAL-NERVOUS-SYSTEM

RATIONALE AND OBJECTIVES. Gd-DTPA is a well-characterized, safe contra st agent frequently used in magnetic resonance imaging (MRI) of the ce ntral nervous system. The purpose of this double-blind, comparative MR I study of brain, spine, trunk, and limbs was to evaluate the safety a nd efficacy of Gd-DOTA versus Gd-DTPA in a large number of patients (n = 1038). METHODS. T1-weighted MRI was performed before contrast and a fter the administration of Gd-DOTA or Gd-DTPA (0.1 mmol/kg). The MR im ages were scored for image quality, and the diagnostic efficacy also w as assessed. Patients were questioned I hour after injection, and adve rse reactions were recorded. RESULTS. Image quality of the T1-weighted MR images without contrast was good or excellent in 89.7% and 91.7% o f the Gd-DOTA and Gd-DTPA groups, respectively (P > 0.2). After contra st, 85.8% (Gd-DOTA) and 88.2% (Gd-DTPA) of the T1-weighted MR images w ere of good to excellent image quality (P > 0.2), significantly less t han before contrast (P < 0.001, both groups). In 82.3% of the Gd-DOTA group and 83.5% of the Gd-DTPA group (P > 0.2), the information obtain ed was more accurate with the administration of contrast agents. In 82 .4% (Gd-DTPA) and 81.9% (Gd-DOTA) of patients, confirmation was obtain ed of diagnosis without contrast, whereas in 17.0% and 17.3% of patien ts, therapy was modified as a result of the use of contrast (P > 0.2, both groups). The MRI investigation was reported as abnormal in 58.3% (Gd-DOTA) and 59.6% of patients (Gd-DTPA), indicating a similar preval ence of disease in each group. Patients responded that 97.8% (Gd-DOTA) and 98.5% (Gd-DTPA) of the investigations went well and adverse react ions, none of them serious, were encountered in 0.97% of Gd-DOTA and 0 .77% of Gd-DTPA groups (P > 0.2, both groups). CONCLUSION. This double -blind, randomized, clinical trial comparing Gd-DTPA and Gd-DOTA revea led no serious adverse reactions, whereas minor adverse reactions were encountered in fewer than 1% of patients. Gd-DOTA is as safe a contra st agent as Gd-DTPA and has similar diagnostic efficacy.