01-12-2013 | Contrast Media
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
Published in: European Radiology | Issue 12/2013
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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.