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)

Maravilla, K.R. y San Juan, D. y Kim, S.J. y Elizondo Riojas, Guillermo y Fink, J.R. y Escobar, W. y Bag, A. y Roberts, Donald R. y Hao, J. y Pitrou, C. y Tsiouris, A.J. y Herskovits, E. y Fiebach, J.B. (2017) 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, 38 (9). pp. 1681-1688. ISSN 0195-6108

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URL o página oficial: http://doi.org/10.3174/ajnr.A5316

Resumen

ABSTRACT BACKGROUNDANDPURPOSE: 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 included279patients.Bothcontrastagents(dose=0.1mmol/kgofbodyweight)wereassessedwith2identicalMRIsatatimeintervalof 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: Forall3readers,imagesofmostpatients(>90%)werescoredgoodorexcellentforoveralllesionvisualizationandcharacterizationwitheithercontrastagent;andthenoninferiorityofgadoteratemeglumineversusgadobutrolwasstatisticallydemonstrated.No significant differences were observed between the 2 contrast agents regarding qualitative end points despite quantitative mean lesion percentageenhancementbeinghigherwithgadobutrol(P<.001).Diagnosticconfidencewashigh/excellentforallreadersin>81%ofthe patientswithbothcontrastagents.Similarpercentagesofpatientswithadverseeventsrelatedtothecontrastagentswereobservedwith gadoterate meglumine (7.8%) and gadobutrol (7.3%), mainly injection site pain. CONCLUSIONS: Thenoninferiorityofgadoteratemeglumineversusgadobutrolforoverallvisualizationandcharacterizationofprimary brain tumors was demonstrated.

Tipo de elemento: Article
Materias: R Medicina > RC Medicina Interna, Psiquiatría, Neurología
Divisiones: Medicina
Usuario depositante: Editor Repositorio
Creadores:
CreadorEmailORCID
Maravilla, K.R.NO ESPECIFICADONO ESPECIFICADO
San Juan, D.NO ESPECIFICADONO ESPECIFICADO
Kim, S.J.NO ESPECIFICADONO ESPECIFICADO
Elizondo Riojas, GuillermoNO ESPECIFICADONO ESPECIFICADO
Fink, J.R.NO ESPECIFICADONO ESPECIFICADO
Escobar, W.NO ESPECIFICADONO ESPECIFICADO
Bag, A.NO ESPECIFICADONO ESPECIFICADO
Roberts, Donald R.NO ESPECIFICADONO ESPECIFICADO
Hao, J.NO ESPECIFICADONO ESPECIFICADO
Pitrou, C.NO ESPECIFICADONO ESPECIFICADO
Tsiouris, A.J.NO ESPECIFICADONO ESPECIFICADO
Herskovits, E.NO ESPECIFICADONO ESPECIFICADO
Fiebach, J.B.NO ESPECIFICADONO ESPECIFICADO
Fecha del depósito: 28 Abr 2020 14:35
Última modificación: 05 Jun 2020 15:06
URI: http://eprints.uanl.mx/id/eprint/17556

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