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Research ArticleAdult Brain
Open Access

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)

K.R. Maravilla, D. San-Juan, S.J. Kim, G. Elizondo-Riojas, J.R. Fink, W. Escobar, A. Bag, D.R. Roberts, J. Hao, C. Pitrou, A.J. Tsiouris, E. Herskovits and J.B. Fiebach
American Journal of Neuroradiology September 2017, 38 (9) 1681-1688; DOI: https://doi.org/10.3174/ajnr.A5316
K.R. Maravilla
aFrom the Department of Radiology (K.R.M., J.R.F.), University of Washington Medical Center, Seattle, Washington
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D. San-Juan
bClinical Research Department (D.S.-J.), National Institute of Neurology and Neurosurgery, Mexico City, Mexico
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S.J. Kim
cDepartment of Radiology (S.J.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
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G. Elizondo-Riojas
dUniversidad Autonoma de Nuevo Leon (G.E.-R.), Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Mexico
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J.R. Fink
aFrom the Department of Radiology (K.R.M., J.R.F.), University of Washington Medical Center, Seattle, Washington
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W. Escobar
eCentro Medico Imbanaco (W.E.), Cali, Colombia
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A. Bag
fDepartment of Radiology (A.B.), University of Alabama, Birmingham, Alabama
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D.R. Roberts
gMedical University of South Carolina (D.R.R.), Charleston, South Carolina
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J. Hao
hGuerbet (J.H., C.P.), Roissy–Charles de Gaulle, France
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C. Pitrou
hGuerbet (J.H., C.P.), Roissy–Charles de Gaulle, France
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A.J. Tsiouris
iDepartment of Radiology (A.J.T.), Weill Cornell Medical College, New York, New York
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E. Herskovits
jDepartment of Radiology (E.H.), University of Maryland, Baltimore, Maryland
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J.B. Fiebach
kCenter for Stroke Research Berlin (J.B.F.), Charité-Universitätsmedizin, Berlin, Germany.
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Article Figures & Data

Figures

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  • Fig 1.
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    Fig 1.

    Patient disposition with numbers of patients enrolled (n = 279) and randomized (n = 274) to undergo 2 identical MR imaging examinations with gadoterate meglumine followed by gadobutrol (arm 1) or with gadobutrol followed by gadoterate meglumine (arm 2). A total of 268 patients received the first contrast agent injection, and 249 patients completed the study with the 2 examinations performed.

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    Fig 2.

    Rate of patients with overall lesion visualization and characterization scored good/excellent or poor/fair. The bar graph shows the rate of patients with overall lesion visualization and characterization scored good/excellent or poor/fair according to each contrast agent and each off-site reader (n = 234 patients for all readers).

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    Fig 3.

    A 46-year-old woman with glioblastoma. T1 spin-echo images (1.5T) after administration of 0.1 mmol/kg of gadoterate meglumine (A) and gadobutrol (B) show an approximate 65-mm lesion. The time between the 2 MR imaging examinations was 7 days. Lesion visualization and characterization were scored as excellent by all 3 blinded readers. The enhancing rim of the lesion is clearly seen on both examinations.

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    Fig 4.

    A 74-year-old man with a high-grade glioma. T1 spin-echo images (1.5T) after administration of 0.1 mmol/kg of gadoterate meglumine (A) and gadobutrol (B) show an approximate 30-mm mass. The time between the 2 MR imaging examinations was 8 days. Lesion visualization and characterization were scored as excellent by all 3 blinded readers. The mass is clearly seen on both examinations and shows no difference in contrast enhancement.

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    Fig 5.

    Classification in preference subgroups for lesion border delineation (A), lesion internal morphology (B), and degree of contrast enhancement (C). The bar graphs show the rate of patients classified in preference subgroups for lesion border delineation (A), lesion internal morphology (B), and degree of contrast enhancement (C), according to each off-site reader (n = 234 patients for all readers; n = 231 patients for reader 1; n = 233 patients for reader 2; n = 232 patients for reader 3), with P > .1 for the 3 end points for all readers (Wilcoxon signed rank test).

Tables

  • Figures
  • Signal-intensity measurements

    LS Meana (SE)LS Meana Difference (95% CI)P Value
    Gadoterate MeglumineGadobutrol
    SNR
        Reader 1266.79 (5.00)281.41 (5.02)−14.61 (−22.77 to −6.46)<.001
        Reader 2157.21 (4.75)167.46 (4.75)−10.26 (−21.58 to 1.07).076
        Reader 3192.94 (4.98)203.35 (4.97)−10.41 (−22.75 to 1.93).098
    CNR
        Reader 1117.22 (7.83)140.84 (7.84)−23.62 (−33.25 to −13.99)<.001
        Reader 264.59 (4.19)72.02 (4.19)−7.42 (−14.87 to 0.03).051
        Reader 382.96 (5.16)96.44 (5.15)−13.48 (−23.43 to −3.54).008
    Percentage enhancement
        Reader 1107.61 (3.93)121.72 (3.93)−14.12 (−18.38 to −9.85)<.001
        Reader 293.90 (3.63)107.12 (3.63)−13.22 (−17.28 to −9.16)<.001
        Reader 398.82 (3.77)114.47 (3.76)−15.66 (−20.52 to −10.79)<.001
    • Note:—SE indicates standard error.

    • ↵a LS means are the means controlled for covariates of the model.

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American Journal of Neuroradiology: 38 (9)
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K.R. Maravilla, D. San-Juan, S.J. Kim, G. Elizondo-Riojas, J.R. Fink, W. Escobar, A. Bag, D.R. Roberts, J. Hao, C. Pitrou, A.J. Tsiouris, E. Herskovits, J.B. Fiebach
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 Sep 2017, 38 (9) 1681-1688; DOI: 10.3174/ajnr.A5316

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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)
K.R. Maravilla, D. San-Juan, S.J. Kim, G. Elizondo-Riojas, J.R. Fink, W. Escobar, A. Bag, D.R. Roberts, J. Hao, C. Pitrou, A.J. Tsiouris, E. Herskovits, J.B. Fiebach
American Journal of Neuroradiology Sep 2017, 38 (9) 1681-1688; DOI: 10.3174/ajnr.A5316
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