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
- 1 March 2009
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Investigative Radiology
- Vol. 44 (3), 168-176
- https://doi.org/10.1097/rli.0b013e318198a0ae
Abstract
To evaluate the diagnostic efficacy (accuracy, sensitivity, specificity) of 1.0 M gadobutrol versus 0.5 M gadopentetate for the classification of lesions as either benign or malignant in patients with known or suspected liver lesions. A multicenter, phase-III, randomized, interindividually controlled comparison study with blinded reader evaluation was performed to investigate the diagnostic efficacy of a bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentetate at a dose of 0.1 mmol Gd/kg BW. The imaging protocol included a dynamic 3D-evaluation, static conventional, and fat saturated T1-weighted sequences. MR datasets were evaluated by 3 independent radiologists. The standard of reference was defined by an independent truth panel (radiologist or hepatologist). The safety evaluation included adverse events, vital signs, and physical examination. A total of 497 of 572 patients were eligible for the final efficacy analysis. Noninferiority of gadobutrol-enhanced magnetic resonance imaging (MRI) for the classification of liver lesions was demonstrated on the basis of diagnostic accuracy determined by the on-site investigators (−0.098, 0.021) as well as for the average reader of the blinded evaluation (−0.096, 0.014) (95% confidence interval), compared with the predefined standard of reference. Very similar increases in sensitivity (ranging from ∼10% to ∼55%) and specificity (ranging from ∼1%–∼18%) compared with precontrast MRI were also observed for the 2 contrast agent groups, with maximum differences of 4%. Very similar, low rates of adverse events were recorded for each of the 2 groups. No clinically relevant changes in vital signs or the results of the physical examination were observed in any patient. This study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol (0.1 mmol/kg body weight) to 0.5 M gadopentetate (0.1 mmol/kg body weight) in the diagnostic assessment of liver lesions with contrast-enhanced MRI. The known excellent safety profile of gadobutrol was confirmed in this clinical trial and is similar to that of gadopentetate.Keywords
This publication has 41 references indexed in Scilit:
- Hepatocellular Carcinoma in Cirrhotic Liver: Double-Contrast-Enhanced, High-Resolution 3.0T-MR Imaging With Pathologic CorrelationInvestigative Radiology, 2008
- Black-Blood Diffusion-Weighted EPI Acquisition of the Liver with Parallel ImagingInvestigative Radiology, 2008
- Liver tumour MRI: what do we need for lesion characterization?Scandinavian Journal of Gastroenterology, 2004
- Liver resection for colorectal metastasesThe Annals of The Royal College of Surgeons of England, 2003
- Surgically Staged Focal Liver Lesions: Accuracy and Reproducibility of Dual-Phase Helical CT for Detection and CharacterizationRadiology, 2003
- Hepatic Tumor Detection: MR Imaging and Conventional US versus Pulse-Inversion Harmonic US of NC100100 during Its Reticuloendothelial System–Specific PhaseRadiology, 2002
- Tumor Ablation with Radio-frequency EnergyRadiology, 2000
- Malignancies in patients with cirrhosis: CT sensitivity and specificity in 200 consecutive transplant patients.Radiology, 1994
- Hepatic metastases and cavernous hemangiomas: distinction with standard- and triple-dose gadoteridol-enhanced MR imaging.Radiology, 1994
- Peripheral washout: a sign of malignancy on dynamic gadolinium-enhanced MR images of focal liver lesions.Radiology, 1994