Assessment of gadobenate dimeglumine for magnetic resonance angiography: phase I studies

Abstract

Rationale and objectives: To assess the vascular contrasting properties of a new MR contrast agent (gadobenate dimeglumine [Gd-BOPTA]), which presents higher relaxivity because of reversible, weak protein interaction, and, to compare these properties with a standard gadolinium agent.

Materials and methods: Two phase I trials compared intraindividually: (A) the vascular contrasting properties of Gd-BOPTA at three doses (0.0125, 0.05, and 0.2 mmol/kg body weight) and two flow rates (0.5 and 2.0 mL/s) in 10 volunteers; and (B) 0.1 mmol/kg body weight doses of Gd-BOPTA and Gd-DTPA at 2.0 mL/s using a modified magnetic resonance angiography (MRA) sequence with a temporal resolution of 1 s/f. Quantitative (ROI analysis) and fully blinded qualitative (reader review) assessment of images was performed.

Results: A dose of 0.2 mmol/kg resulted in higher maximum intensities, longer median peak widths, and larger areas under the curve than did the lower doses (0.0125 mmol/kg and 0.05 mmol/kg). In the intraindividual comparison, Gd-BOPTA demonstrated significantly better vascular enhancement characteristics in terms of signal peak duration (p < 0.05), maximum signal intensity (p < 0.05), and area under the enhancement curve (p < 0.01). The multireader assessment for overall vascular contrast preferred Gd-BOPTA at p < 0.03.

Conclusions: Gd-BOPTA was shown to exhibit preferential and different vascular enhancement properties as compared with Gd-DTPA for MRA.