Objective evaluation of acute adverse events and image quality of gadolinium-based contrast agents (gadobutrol and gadobenate dimeglumine) by blinded evaluation. Pilot study.
OBJECTIVE
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.
Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7510, USA. richsem@med.unc.edu
Richard C
RC
Semelka
Mateus de A
Mde A
Hernandes
Clifton G
CG
Stallings
Mauricio
M
Castillo
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002675:Child, Preschool; D003287:Contrast Media / Q000009:adverse effects; D003875:Drug Eruptions / Q000175:diagnosis / Q000209:etiology*; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects*; D008297:Male; D008536:Meglumine / Q000009:adverse effects / Q000031:analogs & derivatives*; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects*; D010865:Pilot Projects; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016037:Single-Blind Method; D014839:Vomiting / Q000139:chemically induced* / Q000175:diagnosis; D055815:Young Adult
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; C090600:gadobutrol; D008536:Meglumine