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
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : Werner Pennekamp & Daniela Roggenland & Steffen Hering & Stefan Lemburg & Soeren Peters & Sabrina Sterl & Carsten Schwenke & Volkmar Nicolas
- چاپ و سال / کشور: 2010
Description
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 noninferiority. 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-agentdependent 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.
Eur Radiol (2011) 21:1058–1067 DOI 10.1007/s00330-010-2008-z Received: 29 May 2010 / Revised: 12 October 2010 / Accepted: 14 October 2010 / Published online: 21 December 2010
