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Martin R Prince - One of the best experts on this subject based on the ideXlab platform.
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dentate nucleus signal intensity decrease on t1 weighted mr images after switching from gadopentetate dimeglumine to Gadobutrol
Radiology, 2018Co-Authors: Ashkan Heshmatzadeh Behzadi, Zerwa Farooq, Yize Zhao, George Shih, Martin R PrinceAbstract:Dentate signal intensity ratios decreased with time after switching from a linear (gadopentetate dimeglumine) to a macrocyclic (Gadobutrol) agent.
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dentate nucleus signal intensity decrease on t1 weighted mr images after switching from gadopentetate dimeglumine to Gadobutrol
Radiology, 2018Co-Authors: Ashkan Heshmatzadeh Behzadi, Zerwa Farooq, Yize Zhao, George Shih, Martin R PrinceAbstract:Purpose To determine if the increased dentate nucleus signal intensity following six or more doses of a linear gadolinium-based contrast agent (GBCA) (gadopentetate dimeglumine) changes at follow-up examinations performed with a macrocyclic GBCA (Gadobutrol). Materials and Methods This retrospective study included 13 patients with increased dentate nucleus signal intensity following at least six (range, 6-18) gadopentetate dimeglumine administrations who then underwent at least 12 months of follow-up imaging with multiple (range, 3-29) Gadobutrol-enhanced magnetic resonance (MR) examinations. Dentate nucleus-to-pons and dentate nucleus-to-cerebellar peduncle signal intensity ratios were measured by two radiologists blinded to all patient information, and changes were analyzed by using the paired t test and linear regression. Results The mean dentate nucleus-to-pons and dentate nucleus-to-cerebellar peduncle signal intensity ratios increased after gadopentetate dimeglumine administration, from 0.98 ± 0.03 to 1.10 ± 0.03 (P < .0001) and from 0.98 ± 0.030 to 1.09 ± 0.02 (P < .0001), respectively. With Gadobutrol, the mean dentate nucleus-to-pons and dentate nucleus-to-cerebellar peduncle signal intensity ratios decreased to 1.03 ± 0.03 and 1.02 ± 0.04, respectively (P < .0001). With use of a mixed effects model linear regression allowing for each patient to have a different y intercept, mean dentate nucleus-to-pons and dentate nucleus-to-cerebellar peduncle signal intensity ratios decreased with follow-up time (dentate nucleus-to-pons: slope = -0.2% per month [95% confidence interval: -0.0024, -0.0015], R2 = 0.58, P < .0001 for nonzero slope; dentate nucleus-to-cerebellar peduncle: slope = -0.2% per month [95% confidence interval: -0.0024, -0.0015], R2 = 0.61, P < .0001 for nonzero slope). Conclusion Dentate signal intensity increased with at least six gadopentetate dimeglumine-enhanced MR examinations and decreased after switching from a linear (gadopentetate dimeglumine) to a macrocyclic (Gadobutrol) GBCA. © RSNA, 2018 Online supplemental material is available for this article.
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safety of Gadobutrol in over 23 000 patients the gardian study a global multicentre prospective non interventional study
European Radiology, 2017Co-Authors: Martin R Prince, Hae Giu Lee, Chang Hee Lee, Sung Won Youn, In Ho Lee, Woong Yoon, Benqiang Yang, Haiping Wang, Jin WangAbstract:Objectives To investigate the safety and tolerability of Gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting.
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Gadobutrol for contrast enhanced magnetic resonance imaging in elderly patients review of the safety profile from clinical trial post marketing surveillance and pharmacovigilance data
Clinical Radiology, 2015Co-Authors: C Schwenke, Jan Endrikat, Martin R PrinceAbstract:Aim To assess the safety of Gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following Gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18–64 years. Materials and methods Safety data on Gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Results Rates of reported ADRs were lower in elderly patients versus adults aged Conclusions This evaluation involving three large databases demonstrated no greater incidence of ADRs following Gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with Gadobutrol having a favourable safety profile in both age groups.
B Tombach - One of the best experts on this subject based on the ideXlab platform.
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comparison of 1 0 m Gadobutrol and 0 5 m gadopentate dimeglumine enhanced mri in 471 patients with known or suspected renal lesions results of a multicenter single blind interindividual randomized clinical phase iii trial
European Radiology, 2008Co-Authors: B Tombach, Klaus Bohndorf, Wolfgang Brodtrager, C D Claussen, C Duber, M Galanski, E Grabbe, Giacomo Gortenuti, Michael Kuhn, Walter GrossfengelsAbstract:The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M Gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers (‘average reader’) was 83.7% for Gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for Gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for Gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for Gadobutrol and 86.1% for gadopentate dimeglumine. In conclusion, this study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M Gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI.
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do highly concentrated gadolinium chelates improve mr brain perfusion imaging intraindividually controlled randomized crossover concentration comparison study of 0 5 versus 1 0 mol l Gadobutrol
Radiology, 2003Co-Authors: B Tombach, Thomas Benner, Peter Reimer, Gerhard Schuierer, Evamaria Fallenberg, Viviane Geens, Thomas Wels, Gregory A SorensenAbstract:PURPOSE: To assess the potential advantages of using a 1.0 mol/L versus 0.5 mol/L Gadobutrol formulation for magnetic resonance (MR) brain perfusion imaging. MATERIALS AND METHODS: Forty-three healthy volunteers were enrolled in an intraindividually controlled, randomized crossover comparison study. Two Gadobutrol formulations—0.5 and 1.0 mol/L— were randomly injected during two separate treatment periods. For intraindividual comparison of effectiveness parameters, single-section gradient-echo brain perfusion MR imaging was performed under identical conditions for both investigations. Quantitative and qualitative evaluations were performed. Differences between the two Gadobutrol formulations were evaluated at analysis of covariance and tested for statistical significance (P < .05) with a t test. RESULTS: Use of 1.0 mol/L Gadobutrol resulted in a significantly smaller bolus width at half maximum signal intensity decrease, a smaller mean peak time, a higher contrast and contrast-to-noise ratio between gray ...
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value of 1 0 m gadolinium chelates review of preclinical and clinical data on Gadobutrol
European Radiology, 2002Co-Authors: B Tombach, Walter HeindelAbstract:Several preclinical and clinical studies with the first commercially available highly concentrated Gd-chelate Gadobutrol (1 mol/l) are reviewed. Physicochemical, pharmacological, and pharmacokinetic properties, safety analysis, as well as experimental and clinical efficacy studies are highlighted in comparison with 0.5-M Gd-chelates. The 1-mol Gadobutrol has been proven to be safe in an examined dose range from 0.04 up to 0.5 mmol/kg body weight (b.w.). Even in patients with chronic renal impairment, including hemodialysis, Gadobutrol can safely be applied at doses up to 0.3 mmol/kg b.w. For contrast-enhanced MRI in the equilibrium phase, efficacy data analysis shows comparable results to other commercially available extracellular Gd-chelates with lower Gd-concentrations (0.5 M). Studies focused on the potential benefit of a tighter bolus, such as brain perfusion imaging using T2*-effects, document the superiority of a highly concentrated Gd contrast agent. For contrast-enhanced MRA, clinical studies are still ongoing; therefore, the ultimate potential of a more compact bolus, using 1-M Gd-chelates, for contrast-enhanced MRI, has still to be analyzed, especially for time-resolved magnetic resonance angiography.
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using highly concentrated Gadobutrol as an mr contrast agent in patients also requiring hemodialysis safety and dialysability
American Journal of Roentgenology, 2002Co-Authors: B Tombach, Peter Reimer, Viviane Geens, Christoph Bremer, Roland M Schaefer, Wolfgang Ebert, Fritz Matzkies, Jeffrey Eisele, Walter HeindelAbstract:OBJECTIVE. The purpose of our study was to assess the safety and dialysability of Gadobutrol, a new, electrically neutral, and highly concentrated MR contrast agent, in patients who require hemodialysis.SUBJECTS AND METHODS. Eleven patients with end-stage renal failure who required ongoing hemodialysis were enrolled in our prospective study. Gadobutrol (1 mol/L) was injected IV at randomly assigned doses of either 0.1 or 0.3 mmol of gadolinium per kilogram of body weight for contrast-enhanced MR imaging. Hematology, clinical chemistry, and vital signs were closely monitored at baseline and during an observation period of 120 hr after the IV injection of Gadobutrol. To calculate the dialysability, blood samples were drawn before and after each of three hemodialysis sessions. Additional arterial and venous blood sampling was performed during the first hemodialysis session after 30 and 90 min.RESULTS. No Gadobutrol-related changes in hematology, clinical chemistry, or vital signs were detected at either dose...
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renal tolerance of a neutral gadolinium chelate Gadobutrol in patients with chronic renal failure results of a randomized study
Radiology, 2001Co-Authors: B Tombach, Peter Reimer, Viviane Geens, Christoph Bremer, Roland M Schaefer, K Kisters, Walter HeindelAbstract:PURPOSE: To assess the renal tolerance of 1.0 mol/L Gadobutrol as an electrically neutral contrast agent at magnetic resonance (MR) imaging in patients with impaired renal function. MATERIALS AND METHODS: Twenty-one patients with impaired renal function were enrolled in this prospective randomized study and classified into two subgroups according to their creatinine clearance: group 1 (n = 12), less than 80 mL/min ( 0.50 mL/sec); group 2 (n = 9), less than 30 mL/min (<0.50 mL/sec) and not requiring dialysis. Gadobutrol (1.0 mol/L) was injected intravenously at randomly assigned doses of either 0.1 or 0.3 mmol per kilogram of body weight. Changes in vital signs, clinical chemistry, and urinalysis results, including creatinine clearance, were monitored before, at 6 hours, and then every 24 hours until 72 hours (group 1) or 120 hours (group 2) after intravenous injection of Gadobutrol. Hematologic results were checked every other day. RESULTS: No serious adverse even...
Cesare Colosimo - One of the best experts on this subject based on the ideXlab platform.
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Does Higher Gadolinium Concentration Play a Role in the Morphologic Assessment of Brain Tumors? Results of a Multicenter Intraindividual Crossover Comparison of Gadobutrol versus
2016Co-Authors: Gadobenate Dimeglumine, Josef Vymazal, Cesare Colosimo, Mayank Goyal, Miroslav Herman, Z Seidl, Marek Mechl, M Pasowicz, Merit Study, R YeungAbstract:BACKGROUND AND PURPOSE: Gadobenate dimeglumine has proved advantageous compared with other gadolinium-based contrast agents for contrast-enhanced brain MR imaging. Gadobutrol is a more highly concentrated agent (1.0 mol/L). This study intraindividually compared 0.1-mmol/kg doses of these agents for qualitative and quantitative evaluation of brain tumors. MATERIALS AND METHODS: Adult patients with suspected or known brain tumors underwent 2 identical MR imaging examinations at 1.5T, 1 with gadobenate dimeglumine and the other with Gadobutrol, both at a dose of 0.1-mmol/kg body weight. The agents were injected in randomized order separated by 3–14 days. Imaging sequences and acquisition timing were identical for the 2 examina-tions. Three blinded readers evaluated images qualitatively for diagnostic information (lesion extent, delineation, morphology, enhancement, global preference) and quantitatively for CNR and LBR. RESULTS: One hundred fourteen of 123 enrolled patients successfully underwent both examinations. Final diagnoses were intra-axial tumors, metastases, extra-axial tumors, “other ” tumors, and “nontu-mor ” (49, 46, 8, 7, and 4 subjects, respectively). Readers 1, 2, and 3 demonstrated preference for gadobenate dimeglumine in 46 (40.7%), 54 (47.4%), and 49 (43.0%) patients, respectively, compared with 6, 7, and 7 patients for Gadobutrol (P .0001, all readers). Highly significant (P .0001, al
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are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging results of a multicenter intraindividual crossover comparison of Gadobutrol with gadoteridol the truth study
American Journal of Neuroradiology, 2015Co-Authors: Kenneth R. Maravilla, Jan Žižka, Josef Vymazal, Martin P Smith, Mayank Goyal, Miroslav Herman, J J Baima, R Babbel, Manuela Vaneckova, Cesare ColosimoAbstract:BACKGROUND AND PURPOSE: Gadobutrol (Gadavist) and gadoteridol (ProHance) have similar macrocyclic molecular structures, but Gadobutrol is formulated at a 2-fold higher (1 mol/L versus 0.5 mol/L) concentration. We sought to determine whether this difference impacts morphologic contrast-enhanced MR imaging. MATERIALS AND METHODS: Two hundred twenty-nine adult patients with suspected or known brain tumors underwent two 1.5T MR imaging examinations with gadoteridol or Gadobutrol administered in randomized order at a dose of 0.1 mmol/kg of body weight. Imaging sequences and T1 postinjection timing were identical for both examinations. Three blinded readers evaluated images qualitatively and quantitatively for lesion detection and for accuracy in characterization of histologically confirmed brain tumors. Data were analyzed by using the Wilcoxon signed rank test, the McNemar test, and a mixed model. RESULTS: Two hundred nine patients successfully completed both examinations. No reader noted a significant qualitative or quantitative difference in lesion enhancement, extent, delineation, or internal morphology (P values .69 –1.00). One hundred thirty-nine patients had at least 1 histologically confirmed brain lesion. Two readers found no difference in the detection of patients with lesions (133/139 versus 135/139, P .317; 137/139 versus 136/139, P .564), while 1 reader found minimal differences in favor of gadoteridol (136/139 versus 132/139, P .046). Similar findings were noted for the number of lesions detected and characterization of tumors (malignant/benign). Three-reader agreement for characterization was similar for Gadobutrol (66.4% [ 0.43]) versus gadoteridol (70.3% [ 0.45]). There were no significant differences in the incidence of adverse events (P .199).
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are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging results of a multicenter intraindividual crossover comparison of Gadobutrol with gadoteridol the truth study
American Journal of Neuroradiology, 2015Co-Authors: Kenneth R. Maravilla, Jan Žižka, Josef Vymazal, Martin P Smith, Mayank Goyal, Miroslav Herman, J J Baima, R Babbel, Manuela Vaneckova, Cesare ColosimoAbstract:BACKGROUND AND PURPOSE: Gadobutrol (Gadavist) and gadoteridol (ProHance) have similar macrocyclic molecular structures, but Gadobutrol is formulated at a 2-fold higher (1 mol/L versus 0.5 mol/L) concentration. We sought to determine whether this difference impacts morphologic contrast-enhanced MR imaging. MATERIALS AND METHODS: Two hundred twenty-nine adult patients with suspected or known brain tumors underwent two 1.5T MR imaging examinations with gadoteridol or Gadobutrol administered in randomized order at a dose of 0.1 mmol/kg of body weight. Imaging sequences and T1 postinjection timing were identical for both examinations. Three blinded readers evaluated images qualitatively and quantitatively for lesion detection and for accuracy in characterization of histologically confirmed brain tumors. Data were analyzed by using the Wilcoxon signed rank test, the McNemar test, and a mixed model. RESULTS: Two hundred nine patients successfully completed both examinations. No reader noted a significant qualitative or quantitative difference in lesion enhancement, extent, delineation, or internal morphology (P values = .69–1.00). One hundred thirty-nine patients had at least 1 histologically confirmed brain lesion. Two readers found no difference in the detection of patients with lesions (133/139 versus 135/139, P = .317; 137/139 versus 136/139, P = .564), while 1 reader found minimal differences in favor of gadoteridol (136/139 versus 132/139, P = .046). Similar findings were noted for the number of lesions detected and characterization of tumors (malignant/benign). Three-reader agreement for characterization was similar for Gadobutrol (66.4% [κ = 0.43]) versus gadoteridol (70.3% [κ = 0.45]). There were no significant differences in the incidence of adverse events (P = .199). CONCLUSIONS: Gadoteridol and Gadobutrol at 0.1 mmol/kg of body weight provide similar information for visualization and diagnosis of brain lesions. The 2-fold higher gadolinium concentration of Gadobutrol provides no benefit for routine morphologic imaging.
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does higher gadolinium concentration play a role in the morphologic assessment of brain tumors results of a multicenter intraindividual crossover comparison of Gadobutrol versus gadobenate dimeglumine the merit study
American Journal of Neuroradiology, 2012Co-Authors: Z Seidl, Josef Vymazal, Cesare Colosimo, Mayank Goyal, Miroslav Herman, Marek Mechl, M Pasowicz, R Yeung, B Paraniakgieszczyk, B YemenAbstract:BACKGROUND AND PURPOSE: Gadobenate dimeglumine has proved advantageous compared with other gadolinium-based contrast agents for contrast-enhanced brain MR imaging. Gadobutrol is a more highly concentrated agent (1.0 mol/L). This study intraindividually compared 0.1-mmol/kg doses of these agents for qualitative and quantitative evaluation of brain tumors. MATERIALS AND METHODS: Adult patients with suspected or known brain tumors underwent 2 identical MR imaging examinations at 1.5T, 1 with gadobenate dimeglumine and the other with Gadobutrol, both at a dose of 0.1-mmol/kg body weight. The agents were injected in randomized order separated by 3–14 days. Imaging sequences and acquisition timing were identical for the 2 examinations. Three blinded readers evaluated images qualitatively for diagnostic information (lesion extent, delineation, morphology, enhancement, global preference) and quantitatively for CNR and LBR. RESULTS: One hundred fourteen of 123 enrolled patients successfully underwent both examinations. Final diagnoses were intra-axial tumors, metastases, extra-axial tumors, “other” tumors, and “nontumor” (49, 46, 8, 7, and 4 subjects, respectively). Readers 1, 2, and 3 demonstrated preference for gadobenate dimeglumine in 46 (40.7%), 54 (47.4%), and 49 (43.0%) patients, respectively, compared with 6, 7, and 7 patients for Gadobutrol (P CONCLUSIONS: Significantly greater morphologic information and lesion enhancement are achieved on brain MR imaging with 0.1-mmol/kg gadobenate dimeglumine compared with Gadobutrol at an equivalent dose.
Josy Breuer - One of the best experts on this subject based on the ideXlab platform.
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safety of Gadobutrol results from 42 clinical phase ii to iv studies and postmarketing surveillance after 29 million applications
Investigative Radiology, 2016Co-Authors: Jan Endrikat, Kai Vogtlaender, Susan Dohanish, Thomas Balzer, Josy BreuerAbstract:ObjectiveThe aim of this study was to provide a systematic safety analysis of Gadobutrol after more than 29 million applications in clinical routine.Materials and MethodsForty-two clinical development phase II to IV studies on Gadobutrol or comparator and the postmarketing safety surveillance databa
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Safety and Efficacy of Gadobutrol for Contrast-enhanced Magnetic Resonance Imaging of the Central Nervous System: Results from
2016Co-Authors: Juan E Gutierrez, Martin Rosenberg, Josy Breuer, Thomas Balzer, Jorg Seemann, Daniel Haverstock, Jacob Agris, Nicoletta AnzaloneAbstract:Running head recto: Safety and efficacy of Gadobutrol for contrast-enhanced MRI of the CN
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safety and efficacy of Gadobutrol for contrast enhanced magnetic resonance imaging of the central nervous system results from a multicenter double blind randomized comparator study
Magnetic Resonance Insights, 2015Co-Authors: Juan E Gutierrez, Martin Rosenberg, Josy Breuer, Thomas Balzer, Jorg Seemann, Daniel Haverstock, Jacob Agris, Nicoletta AnzaloneAbstract:Purpose: Contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system (CNS) with gadolinium-based contrast agents (GBCAs) is standard of care for CNS imaging and diagnosis because of the visualization of lesions that cause blood–brain barrier breakdown. Gadobutrol is a macrocyclic GBCA with high concentration and high relaxivity. The objective of this study was to compare the safety and efficacy of Gadobutrol 1.0 M vs unenhanced imaging and vs the approved macrocyclic agent gadoteridol 0.5 M at a dose of 0.1 mmol/kg bodyweight. Materials and methods: Prospective, multicenter, double-blind, crossover trial in patients who underwent unenhanced MRI followed by enhanced imaging with Gadobutrol or gadoteridol. Three blinded readers assessed the magnetic resonance images. The primary efficacy variables included number of lesions detected, degree of lesion contrast-enhancement, lesion border delineation, and lesion internal morphology. Results: Of the 402 treated patients, 390 patients received study drugs. Lesion contrast-enhancement, lesion border delineation, and lesion internal morphology were superior for combined unenhanced/Gadobutrol-enhanced imaging vs unenhanced imaging (P < 0.0001 for all). Compared with gadoteridol, Gadobutrol was non-inferior for all primary variables and superior for lesion contrast-enhancement, as well as sensitivity and accuracy for detection of malignant disease. The percentage of patients with at least one drug-related adverse event was similar for Gadobutrol (10.0%) and gadoteridol (9.7%). Conclusion: Gadobutrol is an effective and well-tolerated macrocyclic contrast agent for MRI of the CNS. Gadobutrol demonstrates greater contrast-enhancement and improved sensitivity and accuracy for detection of malignant disease than gadoteridol, likely because of its higher relaxivity.
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Gadobutrol in the central nervous system at three doses results from a phase ii randomized multicenter trial
Journal of Magnetic Resonance Imaging, 2014Co-Authors: Josy Breuer, Juan E Gutierrez, Richard E Latchaw, Robert Lehr, Gregory A SorensenAbstract:Purpose To investigate the efficacy and safety of three doses of Gadobutrol and determine the minimum effective dose for contrast-enhanced MRI of the central nervous system (CNS). Materials and Methods This was a Phase II, multicenter, double-blind, parallel-group controlled study in subjects referred for contrast-enhanced MRI of the CNS. Subjects were randomized to receive Gadobutrol 0.03, 0.1, or 0.3 mmol/kg body weight, and underwent unenhanced, Gadobutrol-enhanced, and comparator-enhanced MRI scans. Three blinded readers assessed the images. Primary efficacy variables were number of lesions detected, border delineation, contrast enhancement, and internal morphology. Results Of the 229 randomized subjects, 173 were evaluated for efficacy. Clinically meaningful improvements in lesion border delineation, contrast enhancement, and internal morphology were observed for 0.1 mmol/kg Gadobutrol. Pair-wise comparisons of a composite score of the four primary variables showed the 0.1 mmol/kg dose to be statistically superior to the 0.03 mmol/kg dose (P = 0.003). The 0.3 mmol/kg dose showed no statistically significant difference with the 0.1 mmol/kg dose. Twenty-two (9.8%) subjects reported at least one treatment-emergent adverse event (TEAE). No TEAE was reported at an incidence >3.5%. Conclusion The 0.1 mmol/kg dose of Gadobutrol was effective and well tolerated for contrast-enhanced MRI of the CNS. J. Magn. Reson. Imaging 2014;39:410–418. © 2013 Wiley Periodicals, Inc.
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Safety of Gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance.
Investigative radiology, 2011Co-Authors: Matthias Voth, Martin Rosenberg, Josy BreuerAbstract:OBJECTIVE To assess the clinical safety and tolerability of the macrocyclic contrast agent Gadobutrol (Gadovist/Gadavist) overall and in specific patient populations based on clinical trials and postmarketing experience. MATERIALS AND METHODS In total, 5545 patients enrolled in 34 prospective clinical studies were evaluated in an integrated analysis of safety. Of all enrolled patients, 4549 received Gadobutrol at a dose of ≤ 0.09 mmol/kg body weight to a maximum of 0.51 mmol/kg body weight, with most patients (53.5%) receiving the recommended dose of >0.09 to 0.11 mmol/kg body weight. Data include comparisons with other extracellular contrast agents and subgroup analyses in pediatric patients, and patients with allergic disposition, renal impairment, hepatic impairment, or cardiovascular disease. Furthermore, worldwide postmarketing safety surveillance results, including nephrogenic systemic fibrosis reports, based on more than 5.7 million estimated applications are described. RESULTS One or more adverse events (AEs) assessed as related to the administration of Gadobutrol were reported by 182 (4.0%) of the 4549 patients who participated in clinical trials. This is comparable to the incidence observed with the comparator contrast agents (74/1844 patients, 4.0%). The most common AEs, independent of drug relationship, were headache, nausea, feeling hot, and dysgeusia. The favorable safety profile of Gadobutrol was also demonstrated in the following specific subpopulations in whom similar incidence rates were seen: pediatric patients aged 2 to 17 years (8/138 patients, 5.8%), patients with severe or moderate renal impairment (9/366 patients, 2.5%), patients with severe or moderate hepatic impairment (9/214 patients, 4.2%), and patients with cardiovascular disorders (42/1506 patients, 2.8%). Having been established in controlled clinical trials, this safety profile was also confirmed by postmarketing surveillance data. With more than 5.7 million estimated administrations of Gadobutrol, a total of 1175 (0.02%) suspected adverse drug reactions have been reported. The most serious adverse reactions seen in postmarketing surveillance included rare reports of cardiac arrest, respiratory arrest, anaphylactoid shock, and nephrogenic systemic fibrosis. Incidence and type of AEs from postmarketing surveillance were consistent with the established safety profile. CONCLUSION The comprehensive analysis of safety data obtained from 34 clinical studies demonstrates that Gadobutrol has an excellent safety profile and a positive benefit risk profile when used in patients in need of contrast-enhanced magnetic resonance imaging. Gadobutrol was well tolerated by adults, by children, by patients with impaired liver or kidney function, and by patients with cardiovascular disease. The favorable safety profile is confirmed by the available postmarketing surveillance data and is compared with that of other gadolinium-based contrast agents.
Kenneth R. Maravilla - One of the best experts on this subject based on the ideXlab platform.
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Comparison of Gadoterate Meglumine and Gadobutrol in the MRI Diagnosis of Primary Brain Tumors: A Double-Blind Randomized Controlled Intraindividual Crossover Study (the REMIND Study).
American Journal of Neuroradiology, 2017Co-Authors: Kenneth R. Maravilla, Daniel San-juan, Soon-bae Kim, G. Elizondo-riojas, James R. Fink, W. Escobar, Asim K. Bag, Donna R. Roberts, J. Hao, C. PitrouAbstract:BACKGROUND AND PURPOSE: Effective management of patients with brain tumors depends on accurate detection and characterization of lesions. This study aimed to demonstrate the noninferiority of gadoterate meglumine versus Gadobutrol for overall visualization and characterization of primary brain tumors. MATERIALS AND METHODS: This multicenter, double-blind, randomized, controlled intraindividual, crossover, noninferiority study included 279 patients. Both contrast agents (dose = 0.1 mmol/kg of body weight) were assessed with 2 identical MRIs at a time interval of 2–14 days. The primary end point was overall lesion visualization and characterization, scored independently by 3 off-site readers on a 4-point scale, ranging from “poor” to “excellent.” Secondary end points were qualitative assessments (lesion border delineation, internal morphology, degree of contrast enhancement, diagnostic confidence), quantitative measurements (signal intensity), and safety (adverse events). All qualitative assessments were also performed on-site. RESULTS: For all 3 readers, images of most patients (>90%) were scored good or excellent for overall lesion visualization and characterization with either contrast agent; and the noninferiority of gadoterate meglumine versus Gadobutrol was statistically demonstrated. No significant differences were observed between the 2 contrast agents regarding qualitative end points despite quantitative mean lesion percentage enhancement being higher with Gadobutrol ( P 81% of the patients with both contrast agents. Similar percentages of patients with adverse events related to the contrast agents were observed with gadoterate meglumine (7.8%) and Gadobutrol (7.3%), mainly injection site pain. CONCLUSIONS: The noninferiority of gadoterate meglumine versus Gadobutrol for overall visualization and characterization of primary brain tumors was demonstrated.
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are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging results of a multicenter intraindividual crossover comparison of Gadobutrol with gadoteridol the truth study
American Journal of Neuroradiology, 2015Co-Authors: Kenneth R. Maravilla, Jan Žižka, Josef Vymazal, Martin P Smith, Mayank Goyal, Miroslav Herman, J J Baima, R Babbel, Manuela Vaneckova, Cesare ColosimoAbstract:BACKGROUND AND PURPOSE: Gadobutrol (Gadavist) and gadoteridol (ProHance) have similar macrocyclic molecular structures, but Gadobutrol is formulated at a 2-fold higher (1 mol/L versus 0.5 mol/L) concentration. We sought to determine whether this difference impacts morphologic contrast-enhanced MR imaging. MATERIALS AND METHODS: Two hundred twenty-nine adult patients with suspected or known brain tumors underwent two 1.5T MR imaging examinations with gadoteridol or Gadobutrol administered in randomized order at a dose of 0.1 mmol/kg of body weight. Imaging sequences and T1 postinjection timing were identical for both examinations. Three blinded readers evaluated images qualitatively and quantitatively for lesion detection and for accuracy in characterization of histologically confirmed brain tumors. Data were analyzed by using the Wilcoxon signed rank test, the McNemar test, and a mixed model. RESULTS: Two hundred nine patients successfully completed both examinations. No reader noted a significant qualitative or quantitative difference in lesion enhancement, extent, delineation, or internal morphology (P values .69 –1.00). One hundred thirty-nine patients had at least 1 histologically confirmed brain lesion. Two readers found no difference in the detection of patients with lesions (133/139 versus 135/139, P .317; 137/139 versus 136/139, P .564), while 1 reader found minimal differences in favor of gadoteridol (136/139 versus 132/139, P .046). Similar findings were noted for the number of lesions detected and characterization of tumors (malignant/benign). Three-reader agreement for characterization was similar for Gadobutrol (66.4% [ 0.43]) versus gadoteridol (70.3% [ 0.45]). There were no significant differences in the incidence of adverse events (P .199).
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are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging results of a multicenter intraindividual crossover comparison of Gadobutrol with gadoteridol the truth study
American Journal of Neuroradiology, 2015Co-Authors: Kenneth R. Maravilla, Jan Žižka, Josef Vymazal, Martin P Smith, Mayank Goyal, Miroslav Herman, J J Baima, R Babbel, Manuela Vaneckova, Cesare ColosimoAbstract:BACKGROUND AND PURPOSE: Gadobutrol (Gadavist) and gadoteridol (ProHance) have similar macrocyclic molecular structures, but Gadobutrol is formulated at a 2-fold higher (1 mol/L versus 0.5 mol/L) concentration. We sought to determine whether this difference impacts morphologic contrast-enhanced MR imaging. MATERIALS AND METHODS: Two hundred twenty-nine adult patients with suspected or known brain tumors underwent two 1.5T MR imaging examinations with gadoteridol or Gadobutrol administered in randomized order at a dose of 0.1 mmol/kg of body weight. Imaging sequences and T1 postinjection timing were identical for both examinations. Three blinded readers evaluated images qualitatively and quantitatively for lesion detection and for accuracy in characterization of histologically confirmed brain tumors. Data were analyzed by using the Wilcoxon signed rank test, the McNemar test, and a mixed model. RESULTS: Two hundred nine patients successfully completed both examinations. No reader noted a significant qualitative or quantitative difference in lesion enhancement, extent, delineation, or internal morphology (P values = .69–1.00). One hundred thirty-nine patients had at least 1 histologically confirmed brain lesion. Two readers found no difference in the detection of patients with lesions (133/139 versus 135/139, P = .317; 137/139 versus 136/139, P = .564), while 1 reader found minimal differences in favor of gadoteridol (136/139 versus 132/139, P = .046). Similar findings were noted for the number of lesions detected and characterization of tumors (malignant/benign). Three-reader agreement for characterization was similar for Gadobutrol (66.4% [κ = 0.43]) versus gadoteridol (70.3% [κ = 0.45]). There were no significant differences in the incidence of adverse events (P = .199). CONCLUSIONS: Gadoteridol and Gadobutrol at 0.1 mmol/kg of body weight provide similar information for visualization and diagnosis of brain lesions. The 2-fold higher gadolinium concentration of Gadobutrol provides no benefit for routine morphologic imaging.
