title: Intra-individual, randomised comparison of the MRI contrast agents gadobutrol and gadoterate in imaging the distal lower limb of patients with known or suspected osteomyelitis, evaluated in an off-site blinded read.
abstract: OBJECTIVE
  To prove that 1.0 M gadobutrol provides superior contrast enhancement in suspicion of osteomyelitis of the feet compared with 0.5 M gadoterate.
  
  
  METHODS
  MRI of feet was performed on 2 separate occasions. Independent injections of 1.0 M gadobutrol and 0.5 M gadoterate at doses of 0.1 mmol Gd/kg body weight were administered per patient. The interval between the two MR examinations was between 24 h and 7 days. Evaluation was performed in an off-site blinded read.
  
  
  RESULTS
  41 patients were eligible for efficacy analysis. Results of secondary efficacy variables did not show statistically significant differences. For the primary efficacy variable, a trend in favour of gadobutrol was seen in the full analysis set (ITT) population resulting in at least non-inferiority. In the per protocol (PP) analysis set gadobutrol had better contrast than gadoterate (Wilcoxon signed rank test, p = 0.0466).
  
  
  CONCLUSIONS
  Imaging of the distal lower limb in this special patient population requires a large number of patients to obtain enough comparative images where non-contrast-agent-dependent factors do not disturb contrast agent efficacy. The ITT analysis showed at least non-inferiority of gadobutrol in comparison to gadoterate. The avoidance of imaging artefacts demonstrates a better outcome for gadobutrol.
authors.affiliation: Department of Radiology and Nuclear Medicine, University Clinics Bergmannsheil, Ruhr-University-Bochum, Buerkle-de-la-Camp Platz 1, 44789 Bochum, Germany. werner.pennekamp@rub.de
authors.forename: Werner
authors.initials: W
authors.lastname: Pennekamp
authors.forename: Daniela
authors.initials: D
authors.lastname: Roggenland
authors.forename: Steffen
authors.initials: S
authors.lastname: Hering
authors.forename: Stefan
authors.initials: S
authors.lastname: Lemburg
authors.forename: Soeren
authors.initials: S
authors.lastname: Peters
authors.forename: Sabrina
authors.initials: S
authors.lastname: Sterl
authors.forename: Carsten
authors.initials: C
authors.lastname: Schwenke
authors.forename: Volkmar
authors.initials: V
authors.lastname: Nicolas
mesh_terms: D000368:Aged; D001835:Body Weight; D003287:Contrast Media / Q000494:pharmacology*; D005121:Extremities / Q000473:pathology*; D005260:Female; D006571:Heterocyclic Compounds / Q000494:pharmacology*; D006801:Humans; D035002:Lower Extremity / Q000473:pathology*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000494:pharmacology*; D010019:Osteomyelitis / Q000188:drug therapy*; D011446:Prospective Studies; D013997:Time Factors
chemical_list: D003287:Contrast Media; D006571:Heterocyclic Compounds; D009942:Organometallic Compounds; C090600:gadobutrol; C050823:gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate