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

AbstractPURPOSE:
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.
AuthorsA J Lemke, B Sander, T Balzer, V Geens, N Hosten, R Felix
JournalRoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin (Rofo) Vol. 167 Issue 6 Pg. 591-8 (Dec 1997) ISSN: 1438-9029 [Print] Germany
Vernacular TitleSicherheit und Nutzen von Gadobutrol bei Patienten mit zerebralen Tumoren (Phase-III-Studie).
PMID9465954 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, English Abstract, Journal Article)
Chemical References
  • Contrast Media
  • Organometallic Compounds
  • gadobutrol
  • Gadolinium
Topics
  • Adenoma (diagnosis)
  • Adult
  • Aged
  • Astrocytoma (diagnosis)
  • Brain Neoplasms (diagnosis, 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

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