title: 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.
abstract: 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.
authors.affiliation: Röntgen- und Strahlenklinik, Klinikum Osnabrück, Osnabrück, Germany. tombach@klinikum-os.de
authors.forename: Bernd
authors.initials: B
authors.lastname: Tombach
authors.forename: Klaus
authors.initials: K
authors.lastname: Bohndorf
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Brodtrager
authors.forename: Claus D
authors.initials: CD
authors.lastname: Claussen
authors.forename: Christoph
authors.initials: C
authors.lastname: Düber
authors.forename: Michael
authors.initials: M
authors.lastname: Galanski
authors.forename: Eckhardt
authors.initials: E
authors.lastname: Grabbe
authors.forename: Giacomo
authors.initials: G
authors.lastname: Gortenuti
authors.forename: Michael
authors.initials: M
authors.lastname: Kuhn
authors.forename: Walter
authors.initials: W
authors.lastname: Gross-Fengels
authors.forename: Renate
authors.initials: R
authors.lastname: Hammerstingl
authors.forename: Brigitte
authors.initials: B
authors.lastname: Happel
authors.forename: Gertraud
authors.initials: G
authors.lastname: Heinz-Peer
authors.forename: Gregor
authors.initials: G
authors.lastname: Jung
authors.forename: Thomas
authors.initials: T
authors.lastname: Kittner
authors.forename: Roberto
authors.initials: R
authors.lastname: Lagalla
authors.forename: Philipp
authors.initials: P
authors.lastname: Lengsfeld
authors.forename: Reinhard
authors.initials: R
authors.lastname: Loose
authors.forename: Raymond H G
authors.initials: RH
authors.lastname: Oyen
authors.forename: Pietro
authors.initials: P
authors.lastname: Pavlica
authors.forename: Christiane
authors.initials: C
authors.lastname: Pering
authors.forename: Roberto
authors.initials: R
authors.lastname: Pozzi-Mucelli
authors.forename: Thorsten
authors.initials: T
authors.lastname: Persigehl
authors.forename: Peter
authors.initials: P
authors.lastname: Reimer
authors.forename: Nomdo S
authors.initials: NS
authors.lastname: Renken
authors.forename: Götz M
authors.initials: GM
authors.lastname: Richter
authors.forename: Ernst J
authors.initials: EJ
authors.lastname: Rummeny
authors.forename: Fritz
authors.initials: F
authors.lastname: Schäfer
authors.forename: Malgorzata
authors.initials: M
authors.lastname: Szczerbo-Trojanowska
authors.forename: Andrzej
authors.initials: A
authors.lastname: Urbanik
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Vogl
authors.forename: Paul
authors.initials: P
authors.lastname: Hajek
mesh_terms: 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
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol; D019786:Gadolinium DTPA