Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial.
The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers ('average reader') was 83.7% for gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for gadobutrol and 86.1% for gadopentate dimeglumine. In conclusion, this study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI.
Tombach
Bernd
B
Röntgen- und Strahlenklinik, Klinikum Osnabrück, Osnabrück, Germany. tombach@klinikum-os.de
Bohndorf
Klaus
K
Brodtrager
Wolfgang
W
Claussen
Claus D
CD
Düber
Christoph
C
Galanski
Michael
M
Grabbe
Eckhardt
E
Gortenuti
Giacomo
G
Kuhn
Michael
M
Gross-Fengels
Walter
W
Hammerstingl
Renate
R
Happel
Brigitte
B
Heinz-Peer
Gertraud
G
Jung
Gregor
G
Kittner
Thomas
T
Lagalla
Roberto
R
Lengsfeld
Philipp
P
Loose
Reinhard
R
Oyen
Raymond H G
RH
Pavlica
Pietro
P
Pering
Christiane
C
Pozzi-Mucelli
Roberto
R
Persigehl
Thorsten
T
Reimer
Peter
P
Renken
Nomdo S
NS
Richter
Götz M
GM
Rummeny
Ernst J
EJ
Schäfer
Fritz
F
Szczerbo-Trojanowska
Malgorzata
M
Urbanik
Andrzej
A
Vogl
Thomas J
TJ
Hajek
Paul
P
D003287:Contrast Media; D005060:Europe / Q000453:epidemiology; D005260:Female; D019786:Gadolinium DTPA / Q000008:administration & dosage; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D007680:Kidney Neoplasms / Q000175:diagnosis* / Q000453:epidemiology*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016037:Single-Blind Method
D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol; D019786:Gadolinium DTPA