[Safety and use of gadobutrol in patients with brain tumors (phase III trial)]

Rofo. 1997 Dec;167(6):591-8. doi: 10.1055/s-2007-1015588.
[Article in German]


Purpose: The purpose of the study was to investigate the use and safety of Gadobutrol, a new low-osmolar, non-ionic contrast agent for MRI using a total dose of 0.3 mmol/kg b.w. on the basis of a clinical phase 3 study.

Methods: 30 patients with primary brain tumours (n = 15) or cerebral metastases (n = 15) were examined via MRI before and after application of a total of 0.3 mmol/kg b.w. given in two fractions (0.1 and 0.2 mmol/kg b.w.). T2-weighted images were performed before, T1-weighted images before, between and after application of contrast material.

Results: In this study one-molar Gadobutrol showed a good tolerance. In half of the cases the contrast between lesion and brain was improved comparing single and triple dose, but this means only a slightly improvement of information for the primary brain tumours compared with single dose. The detected metastatic lesions increased in 40% of the patients after the single dose and in 53% of the patients after cumulative triple dose. There was a consecutive change in therapy in 20% of the patients.

Conclusion: For the differentiation of primary brain tumours the single dose was sufficient, in metastatic lesions triple dose was essential for the detection or exclusion of multifocality.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • English Abstract

MeSH terms

  • Adenoma / diagnosis
  • Adult
  • Aged
  • Astrocytoma / diagnosis
  • Brain Neoplasms / diagnosis*
  • Brain Neoplasms / secondary
  • Contrast Media* / administration & dosage
  • Craniopharyngioma / diagnosis
  • Female
  • Gadolinium* / administration & dosage
  • Hemangioblastoma / diagnosis
  • Humans
  • Magnetic Resonance Imaging / methods*
  • Male
  • Meningioma / diagnosis
  • Middle Aged
  • Oligodendroglioma / diagnosis
  • Organometallic Compounds* / administration & dosage
  • Pituitary Neoplasms / diagnosis
  • Safety


  • Contrast Media
  • Organometallic Compounds
  • gadobutrol
  • Gadolinium