A clinical comparison of the safety and efficacy of MultiHance (gadobenate dimeglumine) and Omniscan (Gadodiamide) in magnetic resonance imaging in patients with central nervous system pathology.
OBJECTIVE
The safety and diagnostic efficacy of MultiHance (gadobenate dimeglumine) in the central nervous system (CNS) were evaluated in a double-blind, multicenter, phase III clinical trial.


METHODS
Two hundred five patients highly suspected of having a CNS lesion (by previous imaging exam) were enrolled at 16 sites in the United States. Patients were randomized to one of three incremental dosing regimens. Magnetic resonance imaging with Omniscan (gadodiamide) at doses of 0.1 and 0.3 mmol/kg was compared with MultiHance (gadobenate dimeglumine) at doses of 0.05 and 0.15 mmol/kg and at 0.1 and 0.2 mmol/kg.


RESULTS
Compared with predose images alone, efficacy was demonstrated in each of the gadobenate dimeglumine and gadodiamide groups (single and cumulative doses) as indicated by the level of diagnostic information, number of lesions detected, and contrast-to-noise ratio measurements. The level of diagnostic information from gadobenate dimeglumine at 0.1 mmol/kg was equivalent to that with gadodiamide at the same dose. One of the two blinded reviewers found equivalence between the gadobenate dimeglumine 0.05 mmol/kg dose and gadodiamide at 0.1 mmol/kg. Both reviewers found the level of diagnostic information to be equivalent after the second dose of contrast for all three dosing regimens. The cumulative doses of gadobenate dimeglumine were well tolerated and as safe as gadodiamide.


CONCLUSIONS
Gadobenate dimeglumine is comparable to gadodiamide in terms of safety and efficacy for imaging of CNS lesions, with a possible advantage in imaging applications owing to enhanced T1 relaxivity.
Runge
V M
VM
University of Kentucky, Department of Diagnostic Radiology, Lexington 40536, USA. runge@worldnet.att.net
Armstrong
M R
MR
Barr
R G
RG
Berger
B L
BL
Czervionke
L F
LF
Gonzalez
C F
CF
Halford
H H
HH
Kanal
E
E
Kuhn
M J
MJ
Levin
J M
JM
Low
R N
RN
Tanenbaum
L N
LN
Wang
A M
AM
Wong
W
W
Yuh
W T
WT
Zoarski
G H
GH
D001932:Brain Neoplasms / Q000473:pathology* / Q000556:secondary*; D003287:Contrast Media / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage / Q000009:adverse effects; D019786:Gadolinium DTPA / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; C064925:gadodiamide; D005682:Gadolinium; D019786:Gadolinium DTPA