PURPOSE: To evaluate the safety of and compare the enhancement characteristics of gadobenate dimeglumine (MultiHance; Bracco Imaging, Milan, Italy) with those of a standard gadolinium chelate (gadopentetate dimeglumine, Magnevist; Schering, Berlin, Germany) in primary and secondary brain tumors on the basis of qualitative and quantitative parameters, on an intraindiviual basis. MATERIALS AND METHODS:Twenty-seven patients with either high-grade glioma or metastases were enrolled in a bicentric intraindividual crossover study to compare lesion enhancement with doses of 0.1 mmol per kilogram of body weight of 0.5 mol/L gadopentetate dimeglumine and 0.5 mol/L gadobenate dimeglumine. MR imaging was performed before injection (T1-weighted spin-echo [SE] and T2-weighted fast SE acquisitions) and at 1, 3, 5, 7, 9, and 16 minutes after injection (T1-weighted SE acquisitions). Qualitative assessment was performed by blinded off-site readers (for 22 patients) and on-site investigators (for 24 patients) in terms of global contrast enhancement, lesion-to-brain contrast, lesion delineation, internal lesion morphology and structure, tumor vascularization, and global image preference. Additional quantitative assessment with region-of-interest analysis was performed by off-site readers alone. Statistical analysis of qualitative data was performed with the Wilcoxon signed rank test, whereas a nonparametric approach was adopted for analysis of quantitative data. RESULTS: Significant (P <.05) preference for gadobenate dimeglumine over gadopentetate dimeglumine was noted both off-site and on-site for the global assessment of contrast enhancement. For off-site readers 1 and 2 and the on-site investigators, respectively, gadobenate dimeglumine was preferred in 13, 17, and 16 patients; gadopentetate dimeglumine was preferred in four, four, and four patients; and equality was found in five, one, and four patients). Similar preference for gadobenate dimeglumine was noted by off-site readers and on-site investigators for lesion-to-brain contrast and all other qualitative parameters. Off-site quantitative evaluation revealed significantly (P <.05) superior enhancement for gadobenate dimeglumine compared with that for gadopentetate dimeglumine at all time points from 3 minutes after injection. CONCLUSION: Significantly superior contrast enhancement of intraaxial enhancing brain tumors was achieved with 0.1 mmol/kg gadobenate dimeglumine compared with that with 0.1 mmol/kg gadopentetate dimeglumine.
RCT Entities:
PURPOSE: To evaluate the safety of and compare the enhancement characteristics of gadobenate dimeglumine (MultiHance; Bracco Imaging, Milan, Italy) with those of a standard gadolinium chelate (gadopentetate dimeglumine, Magnevist; Schering, Berlin, Germany) in primary and secondary brain tumors on the basis of qualitative and quantitative parameters, on an intraindiviual basis. MATERIALS AND METHODS: Twenty-seven patients with either high-grade glioma or metastases were enrolled in a bicentric intraindividual crossover study to compare lesion enhancement with doses of 0.1 mmol per kilogram of body weight of 0.5 mol/L gadopentetate dimeglumine and 0.5 mol/L gadobenate dimeglumine. MR imaging was performed before injection (T1-weighted spin-echo [SE] and T2-weighted fast SE acquisitions) and at 1, 3, 5, 7, 9, and 16 minutes after injection (T1-weighted SE acquisitions). Qualitative assessment was performed by blinded off-site readers (for 22 patients) and on-site investigators (for 24 patients) in terms of global contrast enhancement, lesion-to-brain contrast, lesion delineation, internal lesion morphology and structure, tumor vascularization, and global image preference. Additional quantitative assessment with region-of-interest analysis was performed by off-site readers alone. Statistical analysis of qualitative data was performed with the Wilcoxon signed rank test, whereas a nonparametric approach was adopted for analysis of quantitative data. RESULTS: Significant (P <.05) preference for gadobenate dimeglumine over gadopentetate dimeglumine was noted both off-site and on-site for the global assessment of contrast enhancement. For off-site readers 1 and 2 and the on-site investigators, respectively, gadobenate dimeglumine was preferred in 13, 17, and 16 patients; gadopentetate dimeglumine was preferred in four, four, and four patients; and equality was found in five, one, and four patients). Similar preference for gadobenate dimeglumine was noted by off-site readers and on-site investigators for lesion-to-brain contrast and all other qualitative parameters. Off-site quantitative evaluation revealed significantly (P <.05) superior enhancement for gadobenate dimeglumine compared with that for gadopentetate dimeglumine at all time points from 3 minutes after injection. CONCLUSION: Significantly superior contrast enhancement of intraaxial enhancing brain tumors was achieved with 0.1 mmol/kg gadobenate dimeglumine compared with that with 0.1 mmol/kg gadopentetate dimeglumine.
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