Abstract
Objective
To demonstrate non-inferiority of gadobutrol versus gadobenate dimeglumine by intra-individually comparing 0.1 mmol/kg body weight doses for contrast-enhanced breast magnetic resonance imaging (MRI) and prospectively evaluating lesion detection and characterisation in a multicentre trial.
Methods
Two identical breast MRI examinations were performed in 72 patients with biopsy-proven breast cancer, separated by 1–7 days. Gadobutrol 1.0 M or gadobenate 0.5 M were administered in a randomised order. Lesion detection and characterisation were performed by two independent blinded readers. Lesion tracking, which compared on-site readings and histology from surgery or biopsy, was performed by a third reader. Differences in lesion detection and characterisation were compared between the two contrast agents.
Results
Among 103 lesions, 96 were malignant and 7 were benign. No difference in lesion detection was identified between the contrast agents (82.33 % for gadobutrol, 81.60 % for gadobenate). Assessment of sensitivity in lesion characterisation and Breast Imaging Reporting and Data Systems showed no difference between gadobutrol (92.63 %) and gadobenate (90.53 %). Regarding morphology, there was more non-focal enhancement for gadobutrol than for gadobenate (P = 0.0057).
Conclusion
Non-inferiority of gadobutrol compared with gadobenate was demonstrated for breast lesion detection and sensitivity in lesion characterisation in breast MRI.
Key Points
• Contrast-enhanced magnetic resonance imaging is now widely used for breast problems.
• Lesion detection in breast MRI differs according to the contrast agent.
• Thus we compared gadobutrol 1 M with gadobenate dimeglumine 0.5 M.
• Gadobutrol was non-inferior to gadobenate dimeglumine for detecting and characterising malignant lesions.
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Acknowledgements
The authors would like to thank all colleagues and the clinical team of the Clinique des Grangettes in Chêne-Bougeries/Geneva, the Kantonsspital Baden, Switzerland, and the Policlinico Umberto 1 Roma, Italy. Many thanks to Anne Tardivon, MD, France; Corinne Balleyguier, MD, France; and Julia Camps, MD, Spain, for performing the blinded read. Special thanks to Dr. med. Thomas Wels, Medical Consulting & Key Account Management, Switzerland, for his continuous intellectual contributions and support in study administration.
This study was supported by Bayer Healthcare Pharmaceuticals. The authors are solely responsible for the content of this article. Editorial support was provided by Fiona Murray-Zmijewski PhD, Medicus International, and funded by Bayer Healthcare Pharmaceuticals.
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Pediconi, F., Kubik-Huch, R., Chilla, B. et al. Intra-individual randomised comparison of gadobutrol 1.0 M versus gadobenate dimeglumine 0.5 M in patients scheduled for preoperative breast MRI. Eur Radiol 23, 84–92 (2013). https://doi.org/10.1007/s00330-012-2557-4
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DOI: https://doi.org/10.1007/s00330-012-2557-4