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Intra-individual, randomised comparison of the MRI contrast agents gadobutrol and gadoterate in imaging the distal lower limb of patients with known or suspected osteomyelitis, evaluated in an off-site blinded read

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Abstract

Objective

To prove that 1.0 M gadobutrol provides superior contrast enhancement in suspicion of osteomyelitis of the feet compared with 0.5 M gadoterate.

Methods

MRI of feet was performed on 2 separate occasions. Independent injections of 1.0 M gadobutrol and 0.5 M gadoterate at doses of 0.1 mmol Gd/kg body weight were administered per patient. The interval between the two MR examinations was between 24 h and 7 days. Evaluation was performed in an off-site blinded read.

Results

41 patients were eligible for efficacy analysis. Results of secondary efficacy variables did not show statistically significant differences. For the primary efficacy variable, a trend in favour of gadobutrol was seen in the full analysis set (ITT) population resulting in at least non-inferiority. In the per protocol (PP) analysis set gadobutrol had better contrast than gadoterate (Wilcoxon signed rank test, p = 0.0466).

Conclusion

Imaging of the distal lower limb in this special patient population requires a large number of patients to obtain enough comparative images where non-contrast-agent-dependent factors do not disturb contrast agent efficacy. The ITT analysis showed at least non-inferiority of gadobutrol in comparison to gadoterate. The avoidance of imaging artefacts demonstrates a better outcome for gadobutrol.

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Acknowledgements

Many thanks to all colleagues and the clinical team.

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 Schering Pharma AG, Berlin. The authors are solely responsible for the content of this article.

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Authors and Affiliations

  1. Department of Radiology and Nuclear Medicine, University Clinics Bergmannsheil, Ruhr-University-Bochum, Buerkle-de-la-Camp Platz 1, 44789, Bochum, Germany

    Werner Pennekamp, Daniela Roggenland, Stefan Lemburg, Soeren Peters, Sabrina Sterl & Volkmar Nicolas

  2. Department of Internal Medicine, University Clinics Bergmannsheil, Ruhr-University-Bochum, Buerkle-de-la-Camp Platz 1, 44789, Bochum, Germany

    Steffen Hering

  3. SCO:SSiS-Statistical Consulting, Zeltinger Strasse 58G, 13465, Berlin, Germany

    Carsten Schwenke

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  1. Werner Pennekamp
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Correspondence to Werner Pennekamp.

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Pennekamp, W., Roggenland, D., Hering, S. et al. Intra-individual, randomised comparison of the MRI contrast agents gadobutrol and gadoterate in imaging the distal lower limb of patients with known or suspected osteomyelitis, evaluated in an off-site blinded read. Eur Radiol 21, 1058–1067 (2011). https://doi.org/10.1007/s00330-010-2008-z

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