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
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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.
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.
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.
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.
• 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.
KeywordsGadobutrol Gadoteridol CNS tumours MRI Contrast agent
full analysis set
Gadolinium-based contrast agents
magnetisation prepared rapid gradient echo
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.
- 7.Schaefer FK, Schaefer PJ, Altjohann C et al (2007) A multicenter, site-independent, blinded study to compare the diagnostic accuracy of contrast-enhanced magnetic resonance angiography using 1.0M gadobutrol (Gadovist) to intraarterial digital subtraction angiography in body arteries. Eur J Radiol 61:315–323PubMedCrossRefGoogle Scholar
- 10.Hammerstingl R, Adam G, Ayuso JR et al (2009) Comparison of 1.0 M gadobutrol and 0.5 M gadopentetate dimeglumine-enhanced magnetic resonance imaging in five hundred seventy-two patients with known or suspected liver lesions: results of a multicenter, double-blind, interindividual, randomized clinical phase-III trial. Invest Radiol 44:168–176PubMedCrossRefGoogle Scholar
- 11.Tombach B, Bohndorf K, Brodtrager W et al (2008) Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial. Eur Radiol 18:2610–2619PubMedCrossRefGoogle Scholar
- 14.Anzalone N, Scarabino T, Venturi C et al (2013) Cerebral neoplastic enhancing lesions: Multicenter, randomized, crossover intraindividual comparison between gadobutrol (1.0 M) and gadoterate meglumine (0.5 M) at 0.1 mmol Gd/kg body weight in a clinical setting. Eur J Radiol 82:139–145PubMedCrossRefGoogle Scholar
- 15.Katakami N, Inaba Y, Sugata S et al (2011) Magnetic resonance evaluation of brain metastasis from systemic malignancies with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase II/III study in patients with known or suspected brain metastasis. Invest Radiol 46:411–418PubMedCrossRefGoogle Scholar
- 18.Hadizadeh DR, Von Falkenhausen M, Kukuk GM et al (2010) Contrast material for abdominal dynamic contrast-enhanced 3D MR angiography with parallel imaging: intraindividual equimolar comparison of a macrocyclic 1.0 M gadolinium chelate and a linear ionic 0.5 M gadolinium chelate. AJR Am J Roentgenol 194:821–829PubMedCrossRefGoogle Scholar
- 22.Tatsuno S, Hata Y, Tada S (1996) Double-dose gadolinium DTPA: detectability of intraparenchymal brain metastasis. Nihon Igaku Gakkai Zasshi 56:855–859Google Scholar