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European Radiology

, Volume 23, Issue 12, pp 3287–3295 | Cite as

Intra-individual, randomised comparison of the MRI contrast agents gadobutrol versus gadoteridol in patients with primary and secondary brain tumours, evaluated in a blinded read

  • M. Koenig
  • G. Schulte-Altedorneburg
  • M. Piontek
  • A. Hentsch
  • P. Spangenberg
  • C. Schwenke
  • A. Harders
  • L. HeuserEmail author
Contrast Media

Abstract

Objective

To prove that 1.0 M gadobutrol provides superior contrast enhancement and MRI image characteristics of primary and secondary brain tumours compared with 0.5 M gadoteridol, thereby providing superior diagnostic information.

Methods

Brain MRI was performed in two separate examinations in patients scheduled for neurosurgery. Independent injections of 1.0 M gadobutrol and 0.5 M gadoteridol at doses of 0.1 mmol Gd/kg body weight were administered per patient in randomised order. Evaluation was performed in an off-site blinded read.

Results

Fifty-one patients in the full analysis set (FAS) were eligible for efficacy analysis and 44 for the per-protocol analysis. For the primary efficacy variable “preference in contrast enhancement for one contrast agent or the other”, the rate of “gadobutrol preferred” was estimated at 0.73 (95 % confidence interval 0.61; 0.83), showing significant superiority of gadobutrol over gadoteridol. Calculated lesion-to-brain contrast and the results of all qualitative secondary efficacy variables were also in favour of gadobutrol. Keeping a sufficient time delay after contrast application proved to be essential to get optimal image quality.

Conclusion

Compared with 0.5 M gadoteridol, 1.0 M gadobutrol was proven to have significantly superior contrast enhancement characteristics in a routine MRI protocol of primary and secondary brain tumours.

Key Points

Contrast-enhanced MRI is the imaging technique of choice in CNS tumours.

Intra-individual comparison proved preference of gadobutrol over gadoteridol.

Quantitative results also showed significant superiority regarding lesion-to-brain contrast.

The time interval between contrast administration and image acquisition must be sufficient.

Keywords

Gadobutrol Gadoteridol CNS tumours MRI Contrast agent 

Abbreviations

M

molar

FAS

full analysis set

PP

per-protocol

GBCA

Gadolinium-based contrast agents

SNR

signal-to-noise ratio

LBC

lesion-to-brain contrast

MPRAGE

magnetisation prepared rapid gradient echo

Notes

Acknowledgments

Many thanks to all colleagues and the clinical team of the Knappschaftskrankenhaus Bochum. Special thanks to Dr. med. Thomas Wels, Medical Consulting & Key Account Management, for his continuous intellectual contributions and support in study administration. This study was supported by Bayer Healthcare. Annette Hentsch was an employee of Bayer Healthcare. The other authors were clinical investigators for the trial, which was funded by Bayer Healthcare.

The authors are solely responsible for the contents of this article.

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Copyright information

© European Society of Radiology 2013

Authors and Affiliations

  • M. Koenig
    • 4
  • G. Schulte-Altedorneburg
    • 2
  • M. Piontek
    • 1
  • A. Hentsch
    • 6
  • P. Spangenberg
    • 3
  • C. Schwenke
    • 5
  • A. Harders
    • 7
  • L. Heuser
    • 1
    Email author
  1. 1.Department of Diagnostic and Interventional Radiology, Neuroradiology and Nuclear MedicineUniversitaetsklinikum Knappschaftskrankenhaus GmbHBochumGermany
  2. 2.Department of Diagnostic and Interventional Radiology, Neuroradiology and Nuclear MedicineStädtisches Klinikum Muenchen HarlachingMuenchenGermany
  3. 3.Department of NeurosurgeryUniversitaetsklinikum Knappschaftskrankenhaus GmbHBochumGermany
  4. 4.Department of Diagnostic and Interventional Radiology and NeuroradiologyKlinikum Luenen St. Marien-HospitalLünenGermany
  5. 5.SCO:SSiSBerlinGermany
  6. 6.Radiologisches Institut HohenzollernstrasseKoblenzGermany
  7. 7.Department of Neurosurgery KnappschaftskrankenhausUniversitaetsklinikum Knappschaftskrankenhaus GmbHBochumGermany

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