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Comparison of Gadoterate Meglumine and Gadobutrol in the MRI

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Comparison of Gadoterate Meglumine and Gadobutrol in the MRI LEVEL 1 EBM EXPEDITED PUBLICATION ADULT BRAIN 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) X K.R. Maravilla, X D. San-Juan, X S.J. Kim, X G. Elizondo-Riojas, X J.R. Fink, X W. Escobar, X A. Bag, X D.R. Roberts, X J. Hao, X C. Pitrou, X A.J. Tsiouris, X E. Herskovits, and X J.B. Fiebach EBM 1 ABSTRACT BACKGROUND AND PURPOSE: Effective management of patients with brain tumors depends on accurate detection and characteriza- tion 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 included 279 patients. Both contrast agents (dose ϭ 0.1 mmol/kg of body weight) were assessed with 2 identical MRIs at a time interval of 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: For all 3 readers, images of most patients (Ͼ90%) were scored good or excellent for overall lesion visualization and character- ization with either contrast agent; and the noninferiority of gadoterate meglumine versus gadobutrol was statistically demonstrated. No significant differences were observed between the 2 contrast agents regarding qualitative end points despite quantitative mean lesion percentage enhancement being higher with gadobutrol (P Ͻ .001). Diagnostic confidence was high/excellent for all readers in Ͼ81% of the patients with both contrast agents. Similar percentages of patients with adverse events related to the contrast agents were observed with gadoterate meglumine (7.8%) and gadobutrol (7.3%), mainly injection site pain. CONCLUSIONS: The noninferiority of gadoterate meglumine versus gadobutrol for overall visualization and characterization of primary brain tumors was demonstrated. ABBREVIATIONS: AE ϭ adverse event; CNR ϭ contrast-to-noise ratio; GBCA ϭ gadolinium-based contrast agent; LS ϭ least-squares; r1 ϭ relaxivity adolinium-based contrast agents (GBCAs) have led to im- measured T1 relaxivity (r1) range in plasma at 37°C of 3.4–3.8 Gprovement in the diagnostic accuracy and sensitivity of MR L ϫ mmolϪ1 ϫ sϪ1 at 1.5T and 3.3–3.7 L ϫ mmolϪ1 ϫ sϪ1 at 3T.1 imaging. GBCAs can be classified into linear or macrocyclic Gadobutrol is a nonionic macrocyclic GBCA with a higher r1 agents according to their chemical structure, with macrocyclic range of 4.9–5.5 L ϫ mmolϪ1 ϫ sϪ1 at 1.5T and 4.7–5.3 L ϫ GBCAs showing a higher kinetic stability. mmolϪ1 ϫ sϪ1 at 3T in plasma at 37°C.1 Gadoterate meglumine is an ionic macrocyclic GBCA with a Gadobutrol is the only GBCA formulated at a concentration of 1 mmol/mL, while gadoterate meglumine is formulated at 0.5 mmol/mL, as are all other commercially available GBCAs ap- Received May 3, 2017; accepted after revision June 6. proved for CNS imaging. Both are administered intravenously at From the Department of Radiology (K.R.M., J.R.F.), University of Washington Medi- cal Center, Seattle, Washington; Clinical Research Department (D.S.-J.), National a dose of 0.1 mmol/kg of body weight; thus, gadobutrol is admin- Institute of Neurology and Neurosurgery, Mexico City, Mexico; Department of istered at half the volume of gadoterate meglumine. However, Radiology (S.J.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; Universidad Autonoma de Nuevo Leon (G.E.-R.), Hospital Universita- rio Dr. Jose Eleuterio Gonzalez, Monterrey, Mexico; Centro Medico Imbanaco Please address correspondence to Kenneth R. Maravilla, MD, Department of Radi- (W.E.), Cali, Colombia; Department of Radiology (A.B.), University of Alabama, ology, University of Washington, 1959 NE Pacific, Box 357115, Seattle, WA 98195; Birmingham, Alabama; Medical University of South Carolina (D.R.R.), Charleston, e-mail: [email protected] South Carolina; Guerbet (J.H., C.P.), Roissy–Charles de Gaulle, France; Department Indicates open access to non-subscribers at www.ajnr.org of Radiology (A.J.T.), Weill Cornell Medical College, New York, New York; Depart- Indicates article with supplemental on-line tables. ment of Radiology (E.H.), University of Maryland, Baltimore, Maryland; and Center for Stroke Research Berlin (J.B.F.), Charite´-Universita¨tsmedizin, Berlin, Germany. Evidence-Based Medicine Level 1. This study was supported by Guerbet. http://dx.doi.org/10.3174/ajnr.A5316 AJNR Am J Neuroradiol 38:1681–88 Sep 2017 www.ajnr.org 1681 despite the small differences in relaxivity and in formulated drug lin, Germany; or Gadavist, Bayer HealthCare Pharmaceuticals, concentration, several neuroimaging studies have failed to con- Wayne, New Jersey) were each administered at a single dose of 0.1 clusively demonstrate a clinical advantage for gadobutrol com- mmol/kg of body weight (0.2 mL/kg for gadoterate meglumine, pared with other GBCAs.2-4 0.1 mL/kg for gadobutrol) by intravenous bolus injection at a rate The primary objective of this study was to determine whether of 2 mL/s with an automatic injector. Contrast agent injection was gadoterate meglumine is noninferior to gadobutrol for overall immediately followed by a saline flush of 20–30 mL at the same visualization and characterization of primary brain tumors, using injection rate. To ensure that on-site evaluation of the contrast an intraindividual crossover comparison design. agent was performed under blinded conditions, a third party per- formed the injection. The patient was not aware of the identity of MATERIALS AND METHODS the injected contrast agent. The 2 MR imaging examinations were Study Design performed with a minimum time interval of 48 hours to allow This study was a multicenter, double-blind, randomized, con- contrast washout and prevent any effect of contrast agent carry- trolled intraindividual, 2-sequence, 2-period, crossover noninfe- over, and a maximum time interval of 14 days to minimize any riority study. Patients underwent 2 identical MR imaging exami- potential for lesion change and thus ensure comparability of the 2 nations, 1 with each contrast agent, gadoterate meglumine and examinations. gadobutrol. The sequence of contrast agent administration (gad- oterate meglumine followed by gadobutrol or vice versa) was ran- MR Imaging domly assigned to each patient with a 1:1 allocation ratio. This MR imaging was performed on 1.5T systems in 15 centers and on study was conducted according to the principles in the Declara- 3T systems in 12 centers. Each MR imaging scanner was previ- tion of Helsinki and the Good Clinical Practices guidelines of the ously evaluated for qualification for the study by BioClinica International Conference on Harmonization. In the United (Princeton, New Jersey). It was mandatory that the same MR im- States, the protocol was compliant with the Health Insurance Por- aging scanner and same parameters be used for both examina- tability and Accountability Act. The study was approved by the tions in each patient. Imaging protocol included 3 unenhanced local ethics committee or institutional review board for human sequences: axial T1-weighted (2D spin-echo or gradient recalled- subject research of each institution in which the study was per- echo, or TSE with an echo-train length of Յ3), axial T2-weighted formed. Written informed consent was obtained from all partic- (2D TSE), and axial T2-weighted FLAIR (2D or 3D FLAIR); and 1 ipating patients. The study was registered on https://clinicaltrials. axial T1-weighted sequence post contrast-agent injection ac- gov with identifier NCT02034708. quired with imaging parameters identical to those of the precon- trast axial T1 sequence (On-line Table 1). The postcontrast T1- Patients weighted imaging was initiated 5 Ϯ 1 minutes after the end of the A total of 279 adult patients were enrolled in the study at 27 contrast agent injection. centers worldwide (Mexico, United States, South Korea, and Co- lombia) between June 2014 and September 2015. Patients with Image Evaluation known or highly suspected primary brain (intracranial) tumors All images were evaluated by 3 independent blinded off-site read- detected by previous CT or MR imaging examination and who ers. All were experienced (at least 12 years of experience with an were scheduled for contrast-enhanced MR imaging were in- everyday practice in neuroradiology) and analyzed the images for cluded. Patients were not included if they had a rapidly evolving the following qualitative criteria: overall lesion visualization and brain tumor that could change in appearance between the 2 MR characterization (as the primary end point), lesion border delin- imaging examinations or if they were receiving treatment that eation, visualization of lesion internal morphology, degree of con- could result in a change of lesion appearance between the 2 MR trast enhancement, and level of diagnostic confidence. imaging examinations (eg, radiation therapy, an operation, or Overall visualization and characterization of the lesion (or chemotherapy). Additional noninclusion criteria
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