title: Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study).
abstract: OBJECTIVE
  Gadobutrol (Gadavist) and gadoteridol (ProHance) have similar macrocyclic molecular structures, but gadobutrol is formulated at a 2-fold higher (1 mol/L versus 0.5 mol/L) concentration. We sought to determine whether this difference impacts morphologic contrast-enhanced MR imaging.
  
  
  METHODS
  Two hundred twenty-nine adult patients with suspected or known brain tumors underwent two 1.5T MR imaging examinations with gadoteridol or gadobutrol administered in randomized order at a dose of 0.1 mmol/kg of body weight. Imaging sequences and T1 postinjection timing were identical for both examinations. Three blinded readers evaluated images qualitatively and quantitatively for lesion detection and for accuracy in characterization of histologically confirmed brain tumors. Data were analyzed by using the Wilcoxon signed rank test, the McNemar test, and a mixed model.
  
  
  RESULTS
  Two hundred nine patients successfully completed both examinations. No reader noted a significant qualitative or quantitative difference in lesion enhancement, extent, delineation, or internal morphology (P values = .69-1.00). One hundred thirty-nine patients had at least 1 histologically confirmed brain lesion. Two readers found no difference in the detection of patients with lesions (133/139 versus 135/139, P = .317; 137/139 versus 136/139, P = .564), while 1 reader found minimal differences in favor of gadoteridol (136/139 versus 132/139, P = .046). Similar findings were noted for the number of lesions detected and characterization of tumors (malignant/benign). Three-reader agreement for characterization was similar for gadobutrol (66.4% [κ = 0.43]) versus gadoteridol (70.3% [κ = 0.45]). There were no significant differences in the incidence of adverse events (P = .199).
  
  
  CONCLUSIONS
  Gadoteridol and gadobutrol at 0.1 mmol/kg of body weight provide similar information for visualization and diagnosis of brain lesions. The 2-fold higher gadolinium concentration of gadobutrol provides no benefit for routine morphologic imaging.
authors.affiliation: From the MR Research Laboratory (K.R.M.), University of Washington, Seattle, Washington kmarav@uw.edu.
authors.forename: K R
authors.initials: KR
authors.lastname: Maravilla
authors.affiliation: Department of Radiology (M.P.S.), Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: M P
authors.initials: MP
authors.lastname: Smith
authors.affiliation: Department of Radiology (J.V.), Na Homolce Hospital, Prague, Czech Republic.
authors.forename: J
authors.initials: J
authors.lastname: Vymazal
authors.affiliation: Seaman Family MR Research Centre (M.G.), University of Calgary, Calgary, Alberta, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Goyal
authors.affiliation: Department of Radiology (M.H.), University Hospital Olomouc, Olomouc, Czech Republic.
authors.forename: M
authors.initials: M
authors.lastname: Herman
authors.affiliation: Clinical Radiologists Service Corporation (J.J.B.), Memorial Medical Center, Springfield, Illinois.
authors.forename: J J
authors.initials: JJ
authors.lastname: Baima
authors.affiliation: Good Samaritan Regional Medical Center (R.B.), Corvallis, Oregon.
authors.forename: R
authors.initials: R
authors.lastname: Babbel
authors.affiliation: Department of Magnetic Resonance (M.V.), General University Hospital, Prague, Czech Republic.
authors.forename: M
authors.initials: M
authors.lastname: Vaneckova
authors.affiliation: Department of Diagnostic Radiology (J.Ž.), University Hospital Hradec Králové and Faculty of Medicine in Hradec Králové, Charles University, Prague, Czech Republic.
authors.forename: J
authors.initials: J
authors.lastname: Žižka
authors.affiliation: Istituto di Radiologia (C.C.), Policlinico "Agostino Gemelli," Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Colosimo
authors.affiliation: Department of Radiology (M.U.-Z.), John Paul II Hospital, Krakow, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Urbańczyk-Zawadzka
authors.affiliation: Department of Radiology (M.M.), University Hospital Brno-Bohunice, Brno, Czech Republic.
authors.forename: M
authors.initials: M
authors.lastname: Mechl
authors.affiliation: Department of Radiology (A.K.B.), University of Alabama at Birmingham Medical Center, Birmingham, Alabama.
authors.forename: A K
authors.initials: AK
authors.lastname: Bag
authors.affiliation: Department of Neuroradiology (S.B), University of Pavia, Pavia, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Bastianello
authors.affiliation: Institute for Diagnostic and Interventional Neuroradiology (E.B.), Hannover, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Bueltmann
authors.affiliation: Department of Diagnostic Radiology (T.H.), Kumamoto University, Honjo, Kumamoto, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Hirai
authors.affiliation: Ospedale Valduce (T.F.), Como, Italy.
authors.forename: T
authors.initials: T
authors.lastname: Frattini
authors.affiliation: Global Medical and Regulatory Affairs (M.A.K.), Bracco Imaging SpA, Milan, Italy.
authors.forename: M A
authors.initials: MA
authors.lastname: Kirchin
authors.affiliation: Global Medical and Regulatory Affairs (G.P.), Bracco Diagnostics, Monroe, New Jersey.
authors.forename: G
authors.initials: G
authors.lastname: Pirovano
mesh_terms: D000328:Adult; D000368:Aged; D001932:Brain Neoplasms / Q000175:diagnosis*; D003287:Contrast Media / Q000008:administration & dosage*; D018592:Cross-Over Studies; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage; D006571:Heterocyclic Compounds / Q000008:administration & dosage*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D059906:Neuroimaging / Q000379:methods; D009942:Organometallic Compounds / Q000008:administration & dosage*
chemical_list: D003287:Contrast Media; D006571:Heterocyclic Compounds; D009942:Organometallic Compounds; C062402:gadoteridol; C090600:gadobutrol; D005682:Gadolinium