M Vaneckova1, M Herman2, M P Smith3, M Mechl4, K R Maravilla5, J Weichet6, M V Spampinato7, J Žižka8, F J Wippold9, J J Baima10, R Babbel11, E Bültmann12, R Y Huang13, J-H Buhk14, A Bonafé15, C Colosimo16, S Lui17, M A Kirchin18, N Shen19, G Pirovano19, A Spinazzi19. 1. From the Charles University in Prague (M.V.), First Faculty of Medicine and General University Hospital, Prague, Czech Republic man.van@post.cz. 2. University Hospital Olomouc (M.H.), Olomouc, Czech Republic. 3. Beth Israel Deaconess Medical Center (M.P.S.), Boston, Massachusetts. 4. Faculty of Medicine (M.M.), University Hospital Brno, Masaryk University, Brno, Czech Republic. 5. MR Research Laboratory (K.R.M.), University of Washington, Seattle, Washington. 6. Na Homolce Hospital (J.W.), Prague, Czech Republic. 7. Department of Radiology and Radiological Science (M.V.S.), Medical University of South Carolina, Charleston, South Carolina. 8. University Faculty of Medicine in Hradec Králové (J.Ž.), University Hospital Hradec Králové and Charles University in Prague, Prague, Czech Republic. 9. Mallinckrodt Institute of Radiology (F.J.W.), Washington University School of Medicine, St. Louis, Missouri. 10. Clinical Radiologists, S.C. (J.J.B.), Springfield, Illinois. 11. Good Samaritan Regional Medical Center (R.B.), Corvallis, Oregon. 12. Institute of Diagnostic and Interventional Neuroradiology (E.B.), Hannover, Germany. 13. Harvard Medical School (R.Y.H.), Brigham and Women's Hospital, Boston, Massachusetts. 14. University Medical Center Hamburg Eppendorf (J.-H.B.), Hamburg, Germany. 15. Hopital Gui de Chauliac (A.B.), Montpellier, France. 16. Policlinico "Agostino Gemelli" (C.C.), Rome, Italy. 17. West China Hospital of Sichuan University (S.L.), Chengdu, Sichuan, China. 18. Global Medical & Regulatory Affairs (M.A.K.), Bracco Imaging S.p.A., Milan, Italy. 19. Global Medical & Regulatory Affairs (N.S., G.P., A.S.), Bracco Diagnostics, Monroe, New Jersey.
Abstract
BACKGROUND AND PURPOSE:Gadobenate dimeglumine (MultiHance) has higher r1 relaxivity than gadoterate meglumine (Dotarem) which may permit the use of lower doses for MR imaging applications. Our aim was to compare 0.1- and 0.05-mmol/kg body weight gadobenate with 0.1-mmol/kg body weight gadoterate for MR imaging assessment of brain tumors. MATERIALS AND METHODS: We performed crossover, intraindividual comparison of 0.1-mmol/kg gadobenate with 0.1-mmol/kg gadoterate (Arm 1) and 0.05-mmol/kg gadobenate with 0.1-mmol/kg gadoterate (Arm 2). Adult patients with suspected or known brain tumors were randomized to Arm 1 (70 patients) or Arm 2 (107 patients) and underwent 2 identical examinations at 1.5 T. The agents were injected in randomized-sequence order, and the 2 examinations were separated by 2-14 days. MR imaging scanners, imaging sequences (T1-weighted spin-echo and T1-weighted high-resolution gradient-echo), and acquisition timing were identical for the 2 examinations. Three blinded readers evaluated images for diagnostic information (degree of definition of lesion extent, lesion border delineation, visualization of lesion internal morphology, contrast enhancement) and quantitatively for percentage lesion enhancement and lesion-to-background ratio. Safety assessments were performed. RESULTS: In Arm 1, a highly significant superiority (P < .002) of 0.1-mmol/kg gadobenate was demonstrated by all readers for all end points. In Arm 2, no significant differences (P > .1) were observed for any reader and any end point, with the exception of percentage enhancement for reader 2 (P < .05) in favor of 0.05-mmol/kg gadobenate. Study agent-related adverse events were reported by 2/169 (1.2%) patients after gadobenate and by 5/175 (2.9%) patients after gadoterate. CONCLUSIONS: Significantly superior morphologic information and contrast enhancement are demonstrated on brain MR imaging with 0.1-mmol/kg gadobenate compared with 0.1-mmol/kg gadoterate. No meaningful differences were recorded between 0.05-mmol/kg gadobenate and 0.1-mmol/kg gadoterate.
RCT Entities:
BACKGROUND AND PURPOSE:Gadobenate dimeglumine (MultiHance) has higher r1 relaxivity than gadoterate meglumine (Dotarem) which may permit the use of lower doses for MR imaging applications. Our aim was to compare 0.1- and 0.05-mmol/kg body weight gadobenate with 0.1-mmol/kg body weight gadoterate for MR imaging assessment of brain tumors. MATERIALS AND METHODS: We performed crossover, intraindividual comparison of 0.1-mmol/kg gadobenate with 0.1-mmol/kg gadoterate (Arm 1) and 0.05-mmol/kg gadobenate with 0.1-mmol/kg gadoterate (Arm 2). Adult patients with suspected or known brain tumors were randomized to Arm 1 (70 patients) or Arm 2 (107 patients) and underwent 2 identical examinations at 1.5 T. The agents were injected in randomized-sequence order, and the 2 examinations were separated by 2-14 days. MR imaging scanners, imaging sequences (T1-weighted spin-echo and T1-weighted high-resolution gradient-echo), and acquisition timing were identical for the 2 examinations. Three blinded readers evaluated images for diagnostic information (degree of definition of lesion extent, lesion border delineation, visualization of lesion internal morphology, contrast enhancement) and quantitatively for percentage lesion enhancement and lesion-to-background ratio. Safety assessments were performed. RESULTS: In Arm 1, a highly significant superiority (P < .002) of 0.1-mmol/kg gadobenate was demonstrated by all readers for all end points. In Arm 2, no significant differences (P > .1) were observed for any reader and any end point, with the exception of percentage enhancement for reader 2 (P < .05) in favor of 0.05-mmol/kg gadobenate. Study agent-related adverse events were reported by 2/169 (1.2%) patients after gadobenate and by 5/175 (2.9%) patients after gadoterate. CONCLUSIONS: Significantly superior morphologic information and contrast enhancement are demonstrated on brain MR imaging with 0.1-mmol/kg gadobenate compared with 0.1-mmol/kg gadoterate. No meaningful differences were recorded between 0.05-mmol/kg gadobenate and 0.1-mmol/kg gadoterate.
Authors: H A Rowley; G Scialfa; P-y Gao; J A Maldjian; D Hassell; M J Kuhn; F J Wippold; M Gallucci; B C Bowen; I M Schmalfuss; J Ruscalleda; S Bastianello; C Colosimo Journal: AJNR Am J Neuroradiol Date: 2008-07-03 Impact factor: 3.825
Authors: Z Seidl; J Vymazal; M Mechl; M Goyal; M Herman; C Colosimo; M Pasowicz; R Yeung; B Paraniak-Gieszczyk; B Yemen; N Anzalone; A Citterio; G Schneider; S Bastianello; J Ruscalleda Journal: AJNR Am J Neuroradiol Date: 2012-03-01 Impact factor: 3.825
Authors: Yaqi Shen; Frank L Goerner; Christopher Snyder; John N Morelli; Dapeng Hao; Daoyu Hu; Xiaoming Li; Val M Runge Journal: Invest Radiol Date: 2015-05 Impact factor: 6.016
Authors: C Colosimo; M V Knopp; X Barreau; E Gérardin; M A Kirchin; F Guézénoc; K P Lodemann Journal: Neuroradiology Date: 2004-06-15 Impact factor: 2.804
Authors: Eric M Gale; Peter Caravan; Anil G Rao; Robert J McDonald; Matthew Winfeld; Robert J Fleck; Michael S Gee Journal: Pediatr Radiol Date: 2017-04-13
Authors: Timothy J Kaufmann; Marion Smits; Jerrold Boxerman; Raymond Huang; Daniel P Barboriak; Michael Weller; Caroline Chung; Christina Tsien; Paul D Brown; Lalitha Shankar; Evanthia Galanis; Elizabeth Gerstner; Martin J van den Bent; Terry C Burns; Ian F Parney; Gavin Dunn; Priscilla K Brastianos; Nancy U Lin; Patrick Y Wen; Benjamin M Ellingson Journal: Neuro Oncol Date: 2020-06-09 Impact factor: 12.300
Authors: G K Schneider; J Stroeder; G Roditi; C Colosimo; P Armstrong; M Martucci; A Buecker; P Raczeck Journal: AJNR Am J Neuroradiol Date: 2017-06-22 Impact factor: 3.825
Authors: Mark C DeLano; Maria Vittoria Spampinato; Eric Y Chang; Richard G Barr; Richard J Lichtenstein; Cesare Colosimo; Josef Vymazal; Zhibo Wen; Doris D M Lin; Miles A Kirchin; Gianpaolo Pirovano Journal: J Magn Reson Imaging Date: 2021-05-20 Impact factor: 5.119
Authors: Rajat Chauhan; Nagwa El-Baz; Robert S Keynton; Kurtis T James; Danial A Malik; Mingming Zhu; Ayman El-Baz; Chin K Ng; Paula J Bates; Mohammad Tariq Malik; Martin G O'Toole Journal: Nanomaterials (Basel) Date: 2019-05-07 Impact factor: 5.076