The Benefits of High Relaxivity for Brain Tumor Imaging: Results of a Multicenter Intraindividual Crossover Comparison of Gadobenate Dimeglumine with Gadoterate Meglumine (The BENEFIT Study)

. 2015 Sep ; 36 (9) : 1589-98. [epub] 20150716

Jazyk angličtina Země Spojené státy americké Médium print-electronic

Typ dokumentu časopisecké články, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/pmid26185325

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.

Komentář v

PubMed

Komentář v

PubMed

Zobrazit více v PubMed

Maravilla KR, Maldjian JA, Schmalfuss IM, et al. . Contrast enhancement of central nervous system lesions: multicenter intraindividual crossover comparative study of two MR contrast agents. Radiology 2006;240:389–400 10.1148/radiol.2402051266 PubMed DOI

Rumboldt Z, Rowley HA, Steinberg F, et al. . Multicenter, double-blind, randomized, intra-individual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine in MRI of brain tumors at 3 Tesla. J Magn Reson Imaging 2009;29:760–67 10.1002/jmri.21695 PubMed DOI PMC

Rowley HA, Scialfa G, Gao PY, et al. . Contrast-enhanced MR imaging of brain lesions: a large-scale intraindividual crossover comparison of gadobenate dimeglumine versus gadodiamide. AJNR Am J Neuroradiol 2008;29:1684–91 10.3174/ajnr.A1185 PubMed DOI PMC

Seidl Z, Vymazal J, Mechl M, et al. . 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). AJNR Am J Neuroradiol 2012;33:1050–58 10.3174/ajnr.A3033 PubMed DOI PMC

Shen Y, Goerner FL, Snyder C, et al. . T1 relaxivities of gadolinium-based magnetic resonance contrast agents in human whole blood at 1.5, 3, and 7 T. Invest Radiol 2015;50:330–38 10.1097/RLI.0000000000000132 PubMed DOI

Colosimo C, Knopp MV, Barreau X, et al. . A comparison of Gd-BOPTA and Gd-DOTA for contrast-enhanced MRI of intracranial tumours. Neuroradiology 2004;46:655–65 10.1007/s00234-003-1128-4 PubMed DOI

Khouri Chalouhi K, Papini GD, Bandirali M, et al. . Less is better? Intraindividual and interindividual comparison between 0.075 mmol/kg of gadobenate dimeglumine and 0.1 mmol/kg of gadoterate meglumine for cranial MRI. Eur J Radiol 2014;83:1245–49 10.1016/j.ejrad.2014.03.030 PubMed DOI

Greco A, Parker JR, Ratcliffe CG, et al. . Phase III, randomized, double-blind, cross-over comparison of gadoteridol and gadopentetate dimeglumine in magnetic resonance imaging of patients with intracranial lesions. Australas Radiol 2001;45:457–63 10.1046/j.1440-1673.2001.00957.x PubMed DOI

Maravilla KR, Smith MP, Vymazal J, et al. . 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). AJNR Am J Neuroradiol 2015;36:14–23 10.3174/ajnr.A4154 PubMed DOI PMC

Gutierrez JE, Rosenberg M, Seemann J, et al. . 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. Magn Reson Insights 2015;8:1–10 10.4137/MRI.S19794 PubMed DOI PMC

Anzalone N, Scarabino T, Venturi C, et al. . Cerebral neoplastic enhancing lesions: multicenter, randomized, crossover intraindividual comparison between gadobutrol (1.0M) and gadoterate meglumine (0.5M) at 0.1 mmol Gd/kg body weight in a clinical setting. Eur J Radiol 2013;82:139–45 10.1016/j.ejrad.2011.07.005 PubMed DOI

Kanal E, Maravilla K, Rowley HA. Gadolinium contrast agents for CNS imaging: current concepts and clinical evidence. AJNR Am J Neuroradiol 2014;35:2215–26 10.3174/ajnr.A3917 PubMed DOI PMC

Colosimo C, Ruscalleda J, Korves M, et al. . Detection of intracranial metastases: a multicenter, intrapatient comparison of gadobenate dimeglumine-enhanced MRI with routinely used contrast agents at equal dosage. Invest Radiol 2001;36:72–81 10.1097/00004424-200102000-00002 PubMed DOI

Knopp MV, Runge VM, Essig M, et al. . Primary and secondary brain tumors at MR imaging: bicentric intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine. Radiology 2004;230:55–64 10.1148/radiol.2301021085 PubMed DOI

Essig M, Tartaro A, Tartaglione T, et al. . Enhancing lesions of the brain: intraindividual crossover comparison of contrast enhancement after gadobenate dimeglumine versus established gadolinium comparators. Acad Radiol 2006;13:744–51 10.1016/j.acra.2006.02.056 PubMed DOI

Kuhn MJ, Picozzi P, Maldjian JA, et al. . Evaluation of intraaxial enhancing brain tumors on magnetic resonance imaging: intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for visualization and assessment, and implications for surgical intervention. J Neurosurg 2007;106:557–66 10.3171/jns.2007.106.4.557 PubMed DOI

Koenig M, Schulte-Altedorneburg G, Piontek M, et al. . Intra-individual, randomised comparison of the MRI contrast agents gadobutrol versus gadoteridol in patients with primary and secondary brain tumours, evaluated in a blinded read. Eur Radiol 2013;23:3287–95 10.1007/s00330-013-2946-3 PubMed DOI

Feinstein AR, Cicchetti DV. High agreement but low kappa, I: the problems of two paradoxes. J Clin Epidemiol 1990;43:543–49 10.1016/0895-4356(90)90158-L PubMed DOI

Kanda T, Ishii K, Kawaguchi H, et al. . High signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images: relationship with increasing cumulative dose of a gadolinium-based contrast material. Radiology 2014;270:834–41 10.1148/radiol.13131669 PubMed DOI

Errante Y, Cirimele V, Mallio CA, et al. . Progressive increase of T1 signal intensity of the dentate nucleus on unenhanced magnetic resonance images is associated with cumulative doses of intravenously administered gadodiamide in patients with normal renal function, suggesting dechelation. Invest Radiol 2014;49:685–90 10.1097/RLI.0000000000000072 PubMed DOI

Kanda T, Osawa M, Oba H, et al. . High signal intensity in dentate nucleus on unenhanced T1-weighted MR images: association with linear versus macrocyclic gadolinium chelate administration. Radiology 2015;275:803–09 10.1148/radiol.14140364 PubMed DOI

McDonald RJ, McDonald JS, Kallmes DF, et al. . Intracranial gadolinium deposition after contrast-enhanced MR imaging. Radiology 2015;275:772–82 10.1148/radiol.15150025 PubMed DOI

Quattrocchi CC, Mallio CA, Errante Y, et al. . Gadodiamide and dentate nucleus T1 hyperintensity in patients with meningioma evaluated by multiple follow-up contrast-enhanced magnetic resonance examinations with no systemic interval therapy. Invest Radiol 2015;50:470–72 10.1097/RLI.0000000000000154 PubMed DOI

Radbruch A, Weberling LD, Kieslich PJ, et al. . Gadolinium retention in the dentate nucleus and globus pallidus is dependent on the class of contrast agent. Radiology 2015;275:783–91 10.1148/radiol.2015150337 PubMed DOI

Idée JM, Port M, Robic C, et al. . Role of thermodynamic and kinetic parameters in gadolinium chelate stability. J Magn Reson Imaging 2009;30:1249–58 10.1002/jmri.21967 PubMed DOI

Heverhagen JT, Krombach GA, Gizewski E. Application of extracellular gadolinium-based MRI contrast agents and the risk of nephrogenic systemic fibrosis. Rofo 2014;186:661–69 10.1055/s-0033-1356403 PubMed DOI

Soulez G, Bloomgarden DC, Rofsky NM, et al. . Nephrogenic systemic fibrosis in patients with stages 3 to 5 chronic kidney disease undergoing MRI with the injection of gadobenate dimeglumine or gadoteridol: findings from prospective cohort studies. AJR Am J Roentgenol. In press PubMed

Nandwana SB, Moreno CC, Osipow MT, et al. . Gadobenate dimeglumine administration and nephrogenic systemic fibrosis: is there a real risk in patients with impaired renal function? Radiology 2015. April 15. [Epub ahead of print] 10.1148/radiol.2015142423 PubMed DOI

American College of Radiology (ACR) Manual on Contrast Media. Version 9. 2013. http://www.acr.org/quality-safety/resources/∼/media/37D84428BF1D4E1B9A3A2918DA9E27A3.pdf/. Accessed June 19, 2015.

The Royal Australian and New Zealand College of Radiologists. Guideline on the Use of Gadolinium-Containing MRI Contrast Agents in Patients with Renal Impairment. https://www.nephrology.edu.au/members/documents/GuidelinesontheUseofGadolinium-containingMRIContrastAgents10thSeptember.pdf. Accessed June 19, 2015.

Kirchin MA, Lorusso V, Pirovano G. Compensatory biliary and urinary excretion of gadobenate ion after administration of gadobenate dimeglumine (MultiHance(®)) in cases of impaired hepatic or renal function: a mechanism that may aid in the prevention of nephrogenic systemic fibrosis? Br J Radiol 2015;88:20140526 10.1259/bjr.20140526 PubMed DOI PMC

Noebauer-Huhmann IM, Szomolanyi P, Kronnerwetter C, et al. . Brain tumours at 7T MRI compared to 3T–contrast effect after half and full standard contrast agent dose: initial results. Eur Radiol 2015;25:106–12 10.1007/s00330-014-3351-2 PubMed DOI PMC

Sandstede JJ, Beer M, Lipke C, et al. . Time course of contrast enhancement patterns after Gd-BOPTA in correlation to myocardial infarction and viability: a feasibility study. J Magn Reson Imaging 2001;14:789–94 10.1002/jmri.10007 PubMed DOI

Achenbach M, Figiel JH, Burbelko M, et al. . Prospective comparison of image quality and diagnostic accuracy of 0.5 molar gadobenate dimeglumine and 1.0 molar gadobutrol in contrast-enhanced run-off magnetic resonance angiography of the lower extremities. J Magn Reson Imaging 2010;32:1166–71 10.1002/jmri.22355 PubMed DOI

Morana G, Grazioli L, Kirchin MA, et al. . Solid hypervascular liver lesions: accurate identification of true benign lesions on enhanced dynamic and hepatobiliary phase magnetic resonance imaging after gadobenate dimeglumine administration. Invest Radiol 2011;46:225–39 10.1097/RLI.0b013e3181feee3a PubMed DOI

Schneider G, Probst T, Kirchin MA, et al. . Low-dose gadobenate dimeglumine-enhanced MRI of the kidney for the differential diagnosis of localized renal lesions. Radiol Med 2015. June 19. [Epub ahead of print] 10.1007/s11547-015-0548-7 PubMed DOI PMC

Najít záznam

Citační ukazatele

Nahrávání dat ...

Možnosti archivace

Nahrávání dat ...