Reduced-dose gadobutrol should be considered for contrast-enhanced brain MRI: Study
USA: The use of a 25%-reduced dose of gadobutrol (rd-gadobutrol) should be considered for brain MRI, especially in patients undergoing multiple contrast-enhanced examinations, suggests a recent study.
The study, published in the American Journal of Roentgenology (AJR), found rd-gadobutrol to be non-inferior to a 100%-standard dose of gadoterate (sd-gadoterate) for contrast-enhanced brain MRI.
"A 25% reduced gadobutrol dose demonstrated non-inferior efficacy versus standard-dose gadoterate for contrast-enhanced brain MRI," corresponding author Jan Endrikat of Germany's University Medical School of Saarland elaborated, "warranting particular consideration in patients undergoing multiple contrast-enhanced examinations."
In this international, prospective, multicenter, open-label, crossover trial (LEADER-75), 141 patients (78 men, 63 women; mean age, 58.5 years) with known or suspected CNS pathology underwent contrast-enhanced brain MRI with standard-dose gadoterate (0.1 mmol/ kg). A second MRI with reduced-dose gadobutrol (0.075 mmol/kg) was performed within 15 days if an enhancing lesion was identified.
Key findings of the study include:
- Improvement of rd-gadobutrol over unenhanced images was non-inferior to improvement of sd-gadoterate over unenhanced images using 20% non-inferiority margin for all three primary efficacy measures using mean readings.
- In post-hoc analysis, mean reading for the three primary efficacy measures differed by less than 1% between rd-gadobutrol and sd-gadoterate, supporting equivalence of all measures using a narrow ±5% margin.
- Total lesions detected by mean reading was 301 for rd-gadobutrol versus 291 for sd-gadoterate.
- Mean confidence was 3.3±0.6 for rd-gadobutrol versus 3.3±0.6 for sd-gadoterate.
- Sensitivity (58.7%), specificity (91.8%), and accuracy (70.2%) for malignancy from majority reading were identical for rd-gadobutrol and sd-gadoterate.
- Reader preference was not different.
Comparison of reduced-dose gadobutrol and standard-dose gadoterate versus unenhanced imaging demonstrated noninferiority using a 20% margin for three primary efficacy measures: subjective lesion enhancement, lesion border delineation, lesion internal morphology.
"Various secondary variables also supported non-inferiority of reduced-dose gadobutrol," the authors of the AJR article added.
Reference:
The study titled, "Clinical Efficacy of Reduced Dose Gadobutrol Versus Standard Dose Gadoterate for Contrast-Enhanced MRI of the CNS: An International Multicenter Prospective Crossover Trial (LEADER-75)," is published in the American Journal of Roentgenology.
DOI: https://www.ajronline.org/doi/10.2214/AJR.21.25924
