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


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.
Knopp
M V
MV
Department of Radiology, The Ohio State University Hospitals, Columbus, Ohio 43210-1228, USA. Knopp-1@medctr.osu.edu
Schoenberg
S O
SO
Rehm
C
C
Floemer
F
F
von Tengg-Kobligk
H
H
Bock
M
M
Hentrich
H R
HR
D000328:Adult; D000368:Aged; D019540:Area Under Curve; D003287:Contrast Media / Q000008:administration & dosage; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D019786:Gadolinium DTPA / Q000008:administration & dosage; D006801:Humans; D018810:Magnetic Resonance Angiography; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage; D018709:Statistics, Nonparametric; D014652:Vascular Diseases / Q000175:diagnosis*
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; D019786:Gadolinium DTPA