title: [Diagnosis of cerebral metastasis with standard dose gadobutrol vs. a high dose protocol. Intraindividual evaluation of a phase II high dose study].
abstract: OBJECTIVE
  To assess the effectiveness and safety of normal and high doses of Gadobutrol versus a standard dose of Gadolinium DTPA in the MR evaluation of patients with brain metastases.
  
  
  METHODS
  In a clinical phase-II study 20 patients who had been diagnosed as having brain metastases with CT or MRT were studied prospectively with Gadobutrol, a new nonionic, low osmolality contrast agent. Each patient received an initial injection of 0.1 mmol/kg body weight and an additional dose of 0.2 mmol/kg Gadobutrol 10 min later. Spin-echo images were obtained before and after the two applications of Gadobutrol. Dynamic scanning (Turbo-FLASH) was performed for 3 min after each injection of the contrast agent. Both quantitative and qualitative data were intraindividually evaluated. The primary tumor was a bronchial carcinoma in 11 cases; in 9 other cases there were different primary tumors.
  
  
  RESULTS
  Forty-eight hours after the use of Gadobutrol there were no adverse signs in the clinical examination, vital signs or blood and urine chemistry. Statistical analysis (Friedman test and Wilcoxon test) of the C/N ratios between tumor and white matter, percentage enhancement, and visual assessment rating revealed statistically significant superiority of high-dose Gadobutrol injection in comparison to the standard dose. The percentage enhancement increased on average from 104% after 0.1 mmol/kg to 162% after 0.3 mmol/kg Gadobutrol. Qualitative delineation and contrast of the lesions increased significantly. The use of high-dose Gadobutrol improved the detection of 36 additional lesions in 6 patients.
  
  
  CONCLUSIONS
  The first in vivo results prove the excellent contrast capacity of the nonionic contrast agent Gadobutrol for the diagnosis of intracerebral metastases.
authors.affiliation: Strahlen- und Poliklinik, Universitätsklinikum Rudolf Virchow, Freie Universität Berlin.
authors.forename: T J
authors.initials: TJ
authors.lastname: Vogl
authors.forename: C E
authors.initials: CE
authors.lastname: Friebe
authors.forename: T
authors.initials: T
authors.lastname: Balzer
authors.forename: M G
authors.initials: MG
authors.lastname: Mack
authors.forename: S
authors.initials: S
authors.lastname: Steiner
authors.forename: H
authors.initials: H
authors.lastname: Schedel
authors.forename: W
authors.initials: W
authors.lastname: Pegios
authors.forename: W
authors.initials: W
authors.lastname: Lanksch
authors.forename: D
authors.initials: D
authors.lastname: Banzer
authors.forename: R
authors.initials: R
authors.lastname: Felix
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001921:Brain / Q000473:pathology; D001932:Brain Neoplasms / Q000175:diagnosis / Q000556:secondary*; D002283:Carcinoma, Bronchogenic / Q000175:diagnosis / Q000556:secondary; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000556:secondary; D018288:Carcinoma, Small Cell / Q000175:diagnosis / Q000556:secondary; D003287:Contrast Media / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D019786:Gadolinium DTPA; D006801:Humans; D007089:Image Enhancement; D007275:Injections, Intravenous; D008175:Lung Neoplasms / Q000175:diagnosis; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects; D004369:Pentetic Acid / Q000031:analogs & derivatives
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol; D004369:Pentetic Acid; D019786:Gadolinium DTPA
vernacular_title: Zerebrale Metastasendiagnostik mittels Standarddosis Gadobutrol vs. einem Hochdosisprotokoll. Intraindividuelle Evaluierung einer Phase-II-Hochdosisstudie.