A double blind study to evaluate the tolerability of gadodiamide injection and its effect on renal function in patients undergoing cerebral magnetic resonance imaging.
Gadodiamide injection was administered intravenously to 28 patients with cancer undergoing cerebral magnetic resonance imaging (MRI). Two parallel groups were used to evaluate the safety of single doses of 0.1 and 0.3 mmol per kilogram body weight (kgbw). Adverse events, vital signs, blood chemistry, haematology and urinalysis were the principal measures of safety. Four patients, all in the 0.1 mmol kgbw-1 group, experienced a total of six adverse events. No adverse events were reported in the 0.3 mmol kgbw-1 group. No clinically significant changes in blood chemistry, haematology or urinalysis occurred. No significant changes in renal tubular function or glomerular filtration rate were observed after injection at either dose. Overall, this study suggests that gadodiamide injection is a safe and effective contrast medium for use in patients undergoing cerebral MRI at both the 0.1 and 0.3 mmol kgbw-1 doses.
Lundby
B
B
Nycomed Imaging AS, Oslo, Norway.
Berg
K J
KJ
Lien
H H
HH
Aamdal
S
S
D000328:Adult; D000368:Aged; D001932:Brain Neoplasms / Q000175:diagnosis* / Q000556:secondary; D003287:Contrast Media; D004311:Double-Blind Method; D005260:Female; D019786:Gadolinium DTPA; D006801:Humans; D007668:Kidney / Q000187:drug effects*; D007677:Kidney Function Tests; D008175:Lung Neoplasms / Q000097:blood / Q000652:urine; D008279:Magnetic Resonance Imaging; D008297:Male; D008545:Melanoma / Q000097:blood / Q000175:diagnosis / Q000652:urine; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects*; D004369:Pentetic Acid / Q000009:adverse effects / Q000031:analogs & derivatives*
D003287:Contrast Media; D009942:Organometallic Compounds; D004369:Pentetic Acid; C064925:gadodiamide; D019786:Gadolinium DTPA