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)
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 brai...
| Autores principales: | , , , , , , , , , , , , |
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| Formato: | Artículo |
| Lenguaje: | inglés |
| Publicado: |
American Society of Neuroradiology
2017
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| Materias: | |
| Acceso en línea: | http://eprints.uanl.mx/17556/1/346.pdf |
| _version_ | 1824414933785247744 |
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| author | Maravilla, K.R. San Juan, Daniel Kim, S.J. Elizondo Riojas, Guillermo Fink, J.R. Escobar, W. Bag, A. Roberts, Donald R. Hao, J. Pitrou, C. Tsiouris, A.J. Herskovits, E. Fiebach, J.B. |
| author_facet | Maravilla, K.R. San Juan, Daniel Kim, S.J. Elizondo Riojas, Guillermo Fink, J.R. Escobar, W. Bag, A. Roberts, Donald R. Hao, J. Pitrou, C. Tsiouris, A.J. Herskovits, E. Fiebach, J.B. |
| author_sort | Maravilla, K.R. |
| collection | Repositorio Institucional |
| description | 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. |
| format | Article |
| id | eprints-17556 |
| institution | UANL |
| language | English |
| publishDate | 2017 |
| publisher | American Society of Neuroradiology |
| record_format | eprints |
| spelling | eprints-175562022-03-12T23:55:29Z http://eprints.uanl.mx/17556/ 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. San Juan, Daniel Kim, S.J. Elizondo Riojas, Guillermo Fink, J.R. Escobar, W. Bag, A. Roberts, Donald R. Hao, J. Pitrou, C. Tsiouris, A.J. Herskovits, E. Fiebach, J.B. RC Medicina Interna, Psiquiatría, Neurología 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. American Society of Neuroradiology 2017-09 Article PeerReviewed text en cc_by_nc_nd http://eprints.uanl.mx/17556/1/346.pdf http://eprints.uanl.mx/17556/1.haspreviewThumbnailVersion/346.pdf Maravilla, K.R. y San Juan, Daniel 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 http://doi.org/10.3174/ajnr.A5316 doi:10.3174/ajnr.A5316 |
| spellingShingle | RC Medicina Interna, Psiquiatría, Neurología Maravilla, K.R. San Juan, Daniel Kim, S.J. Elizondo Riojas, Guillermo Fink, J.R. Escobar, W. Bag, A. Roberts, Donald R. Hao, J. Pitrou, C. Tsiouris, A.J. Herskovits, E. Fiebach, J.B. 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) |
| thumbnail | https://rediab.uanl.mx/themes/sandal5/images/online.png |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | RC Medicina Interna, Psiquiatría, Neurología |
| url | http://eprints.uanl.mx/17556/1/346.pdf |
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