K R Maravilla1, D San-Juan2, S J Kim3, G Elizondo-Riojas4, J R Fink5, W Escobar6, A Bag7, D R Roberts8, J Hao9, C Pitrou9, A J Tsiouris10, E Herskovits11, J B Fiebach12. 1. From the Department of Radiology (K.R.M., J.R.F.), University of Washington Medical Center, Seattle, Washington kmarav@uw.edu. 2. Clinical Research Department (D.S.-J.), National Institute of Neurology and Neurosurgery, Mexico City, Mexico. 3. Department of Radiology (S.J.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 4. Universidad Autonoma de Nuevo Leon (G.E.-R.), Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Mexico. 5. From the Department of Radiology (K.R.M., J.R.F.), University of Washington Medical Center, Seattle, Washington. 6. Centro Medico Imbanaco (W.E.), Cali, Colombia. 7. Department of Radiology (A.B.), University of Alabama, Birmingham, Alabama. 8. Medical University of South Carolina (D.R.R.), Charleston, South Carolina. 9. Guerbet (J.H., C.P.), Roissy-Charles de Gaulle, France. 10. Department of Radiology (A.J.T.), Weill Cornell Medical College, New York, New York. 11. Department of Radiology (E.H.), University of Maryland, Baltimore, Maryland. 12. Center for Stroke Research Berlin (J.B.F.), Charité-Universitätsmedizin, Berlin, Germany.
Abstract
BACKGROUND AND PURPOSE: 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 included 279 patients. Both contrast agents (dose = 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 (>90%) were scored good or excellent for overall lesion visualization and characterization 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 < .001). Diagnostic confidence was high/excellent for all readers in >81% 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.
RCT Entities:
BACKGROUND AND PURPOSE: 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 included 279 patients. Both contrast agents (dose = 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 (>90%) were scored good or excellent for overall lesion visualization and characterization 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 < .001). Diagnostic confidence was high/excellent for all readers in >81% 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.
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