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.