Triple-dose versus standard-dose gadopentetate dimeglumine: a randomized study in 199 patients.
To investigate the safety, patient tolerance, and efficacy with 0.3 mmol/kg gadopentetate dimeglumine in magnetic resonance (MR) imaging of the central nervous system (CNS), a phase 3 trial was conducted in 199 patients with suspected CNS lesions. Patients received either 0.1 or 0.3 mmol/kg gadopentate dimeglumine (injection time, 15 seconds and 45 seconds, respectively). T1- and T2-weighted spin-echo sequences were performed at either 0.5 T or 1.5 T. In 80 patients with enhancing brain lesions, contrast-to-noise ratios (C/Ns) were calculated, and lesion-to-brain contrast was evaluated visually. Six patients (6%) in each dose group reported adverse events. Eight adverse events occurred with 0.1 mmol/kg and seven with 0.3 mmol/kg. Vital signs and laboratory values did not change significantly. C/N (P < .05) and visual assessment ratings were higher with 0.3 mmol/kg than with 0.1 mmol/kg. According to these preliminary results, 0.3 mmol/kg gadopentetate dimeglumine is safe and well tolerated when administered at approximately 1 mL/sec.
Haustein
J
J
Department of Clinical Research Diagnostics, Schering AG, Berlin, Germany.
Laniado
M
M
Niendorf
H P
HP
Louton
T
T
Beck
W
W
Planitzer
J
J
Schöffel
M
M
Reiser
M
M
Kaiser
W
W
Schörner
W
W
D000328:Adult; D002493:Central Nervous System Diseases / Q000175:diagnosis; D003287:Contrast Media / Q000008:administration & dosage* / Q000633:toxicity; D004338:Drug Combinations; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage / Q000633:toxicity; D019786:Gadolinium DTPA; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000633:toxicity; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000633:toxicity; D004369:Pentetic Acid / Q000008:administration & dosage / Q000633:toxicity
D003287:Contrast Media; D004338:Drug Combinations; D009942:Organometallic Compounds; D008536:Meglumine; D004369:Pentetic Acid; D005682:Gadolinium; D019786:Gadolinium DTPA