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Comparison of gadoterate meglumine and gadobutrol in MRI diagnosis of brain tumors: a double-blind randomized intra-individually controlled in cross-over study (the REMIND study)
Kenneth Maravilla1, Daniel San Juan Orta2, Sang Joon Kim3, and Guillermo Elizondo Riojas4

1Radiology, University of Washington, Seattle, WA, United States, 2Clinical Research Institute S.C., Tlanepantla de Baz, Mexico, 3Asan medical center / Radiology, Seoul, Korea, Democratic People's Republic of, 4Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Mexico

Synopsis

This double-blind randomized cross-over study was conducted to demonstrate non-inferiority of gadoterate meglumine vs. gadobutrol in MRI diagnosis of brain tumors. Images from two identical MRIs with each agent were evaluated by three independent off-site readers. Overall lesion visualization and characterization was scored as “good” or “excellent” in >90% of patients by all readers. Despite a small difference in signal intensity measurements in favor of gadobutrol, similar results were observed with the two agents regarding overall lesion visualization and characterization or qualitative efficacy criteria. Non-inferiority of gadoterate meglumine vs. gadobutrol in diagnosis of brain tumors by MRI was demonstrated.

Purpose

To demonstrate the non-inferiority of gadoterate meglumine (DOTAREM®, Guerbet, France) vs. gadobutrol (GADOVIST®/GADAVIST®) in Magnetic Resonance Imaging (MRI) diagnosis of primary intracranial tumors.

Methods

A total of 279 patients were included in this double-blind randomized controlled intra-individual cross-over, study. The primary endpoint was overall lesion visualization and characterization, assessed by three independent off-site neuroradiologists on a 4-point scale ranging from “poor” to “excellent”. Secondary endpoints were related to efficacy (qualitative assessment of lesion border delineation, internal morphology, degree of contrast enhancement, diagnostic confidence and quantitative signal intensity measurements) and safety (adverse events). Contrast agents were assessed with two identical MRIs (dose: 0.1 mmol/kg) at a time interval of 2 to 16 days.

Results

Mean (±SD) age was 53.6±15.1 years [range: 18-98]; 64.2% of patients were female. Most frequent diagnoses at previous imaging prior to inclusion in this study were meningioma (49.3%) and glioma (14.9%). Overall lesion visualization and characterization was “good” or “excellent” in more than 90% of patients for all three readers and non-inferiority of gadoterate meglumine vs. gadobutrol was statistically demonstrated. No significant differences were observed between the two contrast agents regarding lesion border delineation, internal morphology and degree of contrast enhancement. Quantitative mean percentage enhancement was slightly higher with gadobutrol (p<0.001). Diagnostic confidence was high or excellent for the three readers in more than 81% of the patients with both contrast agents. The good safety profile was confirmed with similar percentages of patients with post-injection adverse events related to contrast agents (7.8% related to gadoterate meglumine vs. 7.3% related to gadobutrol). No serious adverse reactions were encountered with either agent.

Conclusion

This study demonstrates non-inferiority of gadoterate meglumine vs. gadobutrol in diagnosis of brain tumors by MRI. Although quantitative signal intensity measurements showed a small difference in favor of gadobutrol that is explained by its slightly higher relaxivity, this did not result in any clinical benefit since no differences were demonstrated for overall diagnostic evaluation of the images for any of the blinded readers.

Acknowledgements

For the REMIND Study investigators.

References

No reference found.
Proc. Intl. Soc. Mag. Reson. Med. 25 (2017)
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