Inter- and intra-individual comparative study of two gadolinium-based agents: A pilot study.

PURPOSE: The aim of the study was to evaluate the acute adverse events rate and enhancement properties of gadoterate meglumine (Dotarem(®)) and gadobenate dimeglumine (MultiHance(®)) in a small-scale controlled double-blinded study, using inter- and intra-individual comparisons.

MATERIALS AND METHODS: Forty-one randomly selected patients were scanned with Dotarem(®). The rate of adverse reactions, qualitative and quantitative image evaluation was performed vs. a control group of 46 patients who underwent MultiHance(®) over the same 1-month time period (population 1), and 27 patients who underwent both Dotarem(®) and MultiHance(®)-enhanced body MRI studies within an 18-month period (population 2). Data were subjected to statistical analysis.

RESULTS: Only 1 mild acute adverse event (vomiting) was observed in population 1 (with Dotarem(®)). Blinded assessment of image quality was good for both agents in all patients. Population 1 showed significantly higher liver percentage enhancement with MultiHance(®) (p < 0.0001). There was a trend to higher pancreas-to-liver enhancement with Dotarem(®), significant in population 2 (p = 0.0333).

CONCLUSION: This small-scale multi-blinded study characterizes a strategy to objectively assess intravenous contrast agents, which may be an ideal method to evaluate whether a new contrast agent should be introduced for clinical use at any institution, and to re-evaluate the agent in standard use. Whenever available, intra-individual assessment may be ideal.