A clinical comparison of the safety and efficacy of MultiHance (gadobenatedimeglumine) and Omniscan (gadodiamide) in magnetic resonance imaging in patients with central nervous system pathology

RATIONALE AND OBJECTIVES. 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. Magne tic resonance imaging with Omniscan (gadodiamide) at doses of 0.1 and 0.3 m mol/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 e ach of the gadobenate dimeglumine and gadodiamide groups (single and cumula tive doses) as indicated by the level of diagnostic information, number of lesions detected, and contrast-to-noise ratio measurements. The level of di agnostic information from gadobenate dimeglumine at 0.1 mmol/kg was equival ent to that with gadodiamide at the same dose. One of the two blinded revie wers found equivalence between the gadobenate dimeglumine 0.05 mmol/kg dose and gadodiamide at 0.1 mmol/kg. Both reviewers found the level of diagnost ic information to be equivalent after the second dose of contrast for all t hree dosing regimens. The cumulative doses of gadobenate dimeglumine were w ell tolerated and as safe as gadodiamide. CONCLUSIONS. Gadobenate dimeglumine is comparable to gadodiamide in terms o f safety and efficacy for imaging of CNS lesions, with a possible advantage in imaging applications owing to enhanced T1 relaxivity.