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.

Objective evaluation of acute adverse events and image quality of gadolinium-based contrast agents (gadobutrol and gadobenate dimeglumine) by blinded evaluation. Pilot study.

PURPOSE: The purpose was to objectively evaluate a recently FDA-approved gadolinium-based contrast agent (GBCA) in comparison to our standard GBCA for acute adverse events and image quality by blinded evaluation. METHODS: Evaluation was made of a recently FDA-approved GBCA, gadobutrol (Gadavist; Bayer), in comparison to our standard GBCA, gadobenate dimeglumine (MultiHance; Bracco), in an IRB- and HIPAA-compliant study. Both the imaging technologist and patient were not aware of the brand of the GBCA used. A total of 59 magnetic resonance studies were evaluated (59 patients, 31 men, 28 women, age range of 5-85 years, mean age of 52 years). Twenty-nine studies were performed with gadobutrol (22 abdominal and 7 brain studies), and 30 studies were performed with gadobenate dimeglumine (22 abdominal and 8 brain studies). Assessment was made of acute adverse events focusing on objective observations of vomiting, hives, and moderate and severe reactions. Adequacy of enhancement was rated as poor, fair and good by one of two experienced radiologists who were blinded to the type of agent evaluated. RESULTS: No patient experienced acute adverse events with either agent. The target minor adverse events of vomiting or hives, and moderate and severe reactions were not observed in any patient. Adequacy of enhancement was rated as good for both agents in all patients. CONCLUSIONS: Objective, blinded evaluation is feasible and readily performable for the evaluation of GBCAs. This proof-of-concept study showed that both GBCAs evaluated exhibited consistent good image quality and no noteworthy adverse events.